[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-foot-ulcer-dfu\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-foot-ulcer-dfu":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,48,80,114,140,169,193,228,254,279,306,327,350,376,406,427,455,478,505,530,558,586,606,626,658],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100599588","phase-4-randomized-evaluation-of-nonhealing-diabetic-foot-ulcers-with-exclusive-wound-therapy-100599588",false,"NCT07086443","Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating Placental Derived Allografts and Standard of Care in the Treatment of Nonhealing Diabetic Foot Ulcers Using Matched Controls","RENEW","Inclusion Criteria:\n\n* The potential subject must be at least 18 years of age or older.\n* The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.\n* At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the imaging device length times width.\n* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.\n* The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.\n* The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.\n* The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n  1. ABI between 0.7 and ≤ 1.3;\n  2. TBI ≥ 0.6;\n  3. TCOM ≥ 40 mmHg;\n  4. PVR: biphasic. 8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n* The potential subject must have a target ulcer located on the 50% below the malleolus and not on the dorsal toes.\n* The ulcer must be offloaded for at least 14 days prior to enrollment.\n* The potential subject must consent to using the prescribed offloading method for the duration of the study.\n* The potential subject must agree to attend the weekly study visits required by the protocol.\n* The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n* The potential subject is known to have a life expectancy of \\\u003C 6 months.\n* The potential subject's target ulcer is not secondary to diabetes.\n* The target ulcer is infected or there is cellulitis in the surrounding skin.\n* The target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the target ulcer.\n* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n* The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n* The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n* The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.\n* The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.\n* The potential subject has end stage renal disease requiring dialysis.\n* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n* The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n* The potential subject has a malnutrition.\n* The potential subject has a known allergy or sensitivity to PBS, IPA, processing solutions, reagents, or latex.","ALL","18 Years",{"count":21,"type":22},350,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.",[28,29,30,31,32,33,34],"Diabetic Foot Ulcer","DFU","Diabetic Foot Ulcer (DFU)","Foot Ulcer Due to Type 1 Diabetes Mellitus","Foot Ulcer Due to Type 2 Diabetes Mellitus","Ulcer","Ulcer Foot","RECRUITING","2026-05-18",{"date":38,"type":39},"2026-05-19","ACTUAL",{"date":41,"type":39},"2025-07-11",{"date":43,"type":22},"2027-07",{"name":45,"class":46},"Sequence LifeScience, Inc.","INDUSTRY",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100639513","risk-perception-intervention-for-high-risk-diabetic-foot-100639513","NCT07581262","Risk Perception Intervention for High-Risk Diabetic Foot","Construction and Application of a Foot Ulcer Risk Perception Intervention Program for Diabetic Patients With High-risk Foot Based on Information Framework Effect","Inclusion Criteria:\n\n1. Age ≥ 18 years old with good communication and cognitive abilities.\n2. Meet the World Health Organization (WHO) diagnostic criteria for Type 1 or Type 2 Diabetes Mellitus.\n3. Meet the diagnostic criteria for high-risk diabetic foot according to the International Working Group on the Diabetic Foot (IWGDF) 2023 standards.\n4. Proficient in the use of a smartphone and related applications (e.g., WeChat).\n5. Voluntarily participate in the study and provide signed informed consent.\n\nExclusion Criteria:\n\n1. Patients with impaired consciousness, severe organ dysfunction, or other physical disabilities that lead to being bedbound or unable to perform foot care.\n2. Patients with peripheral neuropathy caused by non-diabetic factors (e.g., toxic, nutritional, or hereditary neuropathies).\n3. Patients with gestational diabetes or those with pre-existing diabetes who are currently pregnant.",{"count":56,"type":22},90,[58],"NA","This study aims to evaluate the effect of health education based on information framing effects on foot ulcer risk perception in patients at high risk of diabetic foot.\n\nStudy Design:\n\nA randomized controlled trial with three groups:\n\nExperimental Group 1 (Gain-Framed): Participants received a benefit framing message that emphasized the benefits of standardized foot care in reducing the likelihood and severity of foot ulcers, with an aim to reshape patients' perception of risk.\n\nExperimental Group 2 (Loss-Framed):Participants received a loss frame message that emphasized that neglecting foot care would increase the likelihood and severity of foot ulcers. The message was designed to awaken patients' awareness of crisis and risk perception.\n\nControl Group (Routine Messaging):Participants received the usual content of care in the endocrinology department without a specific framework.\n\nParticipants:\n\nDiabetic foot patients at high risk from experimental group 1, experimental group 2, and control group 3. Inclusion criteria included adults with a diagnosis of diabetic foot at high risk.\n\nIntervention:\n\nThe Total Study Period consisted of an intervention phase and a follow-up phase. The intervention phase started at the time of enrollment and lasted until the fourth week after discharge. The follow-up period lasted for 3 months. Data on local indicators were collected at baseline\u002Fbefore the intervention (T0), immediately after the intervention (T1), 1 month after the intervention (T2) and 3 months after the intervention (T3).\n\nOutcome Measures:\n\nPrimary Outcomes:\n\nFoot ulcer risk perception: Assessed using The Tripartite Model of Risk Perception Scale.\n\nSecondary Outcomes:\n\nFoot care behavior score: Assessed using The Nottingham Foot Care Assessment Scale; Self-efficacy: Assessed using The Diabetes Self-Efficacy Scale; Intention to delay seeking medical help score:Assessed using the Questionnaire on Intention to Delay Seeking Medical Care for Patients with High-Risk Diabetic Foot; the incidence\u002Frecurrence rate of foot ulcers, and various laboratory indicators.",[61,30,62,63],"Diabetes Mellitus","Risk Perception","Peripheral Neuropathy With Type 2 Diabetes",[65,66,67,68],"diabetes mellitus","high risk foot","diabetic foot ulcer","risk perception","NOT_YET_RECRUITING","2026-05-06",{"date":72,"type":39},"2026-05-12",{"date":74,"type":22},"2026-05-01",{"date":76,"type":22},"2026-12-31",{"name":78,"class":79},"The Third Affiliated Hospital of Soochow University","OTHER",{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":97,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":47},"100634554","paw-hydrogel-for-chronic-wound-healing-100634554","NCT07541196","PAW-Hydrogel for Chronic Wound Healing","Efficacy and Safety of a Carbopol® 940 Hydrogel Functionalized With Plasma-Activated Water (PAW) in the Treatment of Chronic Wounds: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults ≥ 18 years of age.\n* Diagnosis of chronic wound (diabetic foot ulcer Wagner grade 1-2, pressure injury grade I-III, dehiscent surgical wound, venous or arterial ulcer) with duration \\> 3 months.\n* Wound surface area between 2 cm² and 20 cm².\n* For diabetic patients: HbA1c \\\u003C 9% (stable metabolic control).\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Clinical or radiological evidence of osteomyelitis (Wagner grade \\> 3).\n* Severe arterial insufficiency (ankle-brachial index \\\u003C 0.5).\n* Use of systemic corticosteroids or immunosuppressants.\n* Pregnancy or lactation.\n* Known autoimmune skin disease (e.g., pemphigus, epidermolysis bullosa).\n* Active malignancy or undergoing chemotherapy\u002Fradiotherapy.\n* Participation in another interventional clinical trial within 30 days prior to screening.",{"count":88,"type":22},50,[58],"The goal of this randomized controlled trial is to evaluate the efficacy and safety of a novel hydrogel made of Carbopol® 940 functionalized with Plasma-Activated Water (PAW) in patients with chronic wounds (diabetic foot ulcers, pressure injuries, dehiscent wounds, arterial and venous ulcers). The main questions it aims to answer are:\n\n* Does PAW-hydrogel accelerate wound closure (reduction in surface area) compared to standard advanced wound care?\n* Does PAW-hydrogel reduce bacterial load in the wound bed?\n* Is PAW-hydrogel safe and well-tolerated (local adverse events, pain)?\n\nParticipants will be randomly assigned to one of two groups:\n\n* Experimental group: Topical application of PAW-hydrogel (Carbopol® 940 neutralized to pH 5.5, loaded with reactive oxygen and nitrogen species from plasma activation) 2-3 times per week.\n* Control group: Standard advanced wound care (cleaning, debridement, conventional dressings).\n\nWound area (planimetry), bacterial load (semi-quantitative cultures), pain (Visual Analog Scale), tissue quality (Bates-Jensen scale), and adverse events will be assessed over a 12-week follow-up period.",[30,92,93,94,95,96],"Pressure Ulcer (PU)","Wound Dehiscence","Venous Leg Ulcer","Arterial Ulcer","Chronic Wound",[98,99,100,101,102,103,104],"Plasma-Activated Water","PAW","Hydrogel","Chronic Wounds","Diabetic Foot","Wound Healing","RONS","2026-04-14",{"date":107,"type":39},"2026-04-21",{"date":109,"type":22},"2026-04-20",{"date":111,"type":22},"2027-07-30",{"name":113,"class":79},"Benjamín Gonzalo Rodríguez Méndez",{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":47},"100631249","phase-1-phase-1-study-of-velgraft-a-living-cellular-construct-in-the-management-of-chronic-diabetic-foot-ulcers-which-have-attained-granulation-tissue-100631249","NCT07498218","Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue","A Prospective, Multi-center, Randomized, Double-blind, Controlled, Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patient has current diagnosis of type 1 or type 2 diabetes mellitus\n3. Patient's ulcer has been present for greater than 4 weeks and less than 24 weeks at the screening visit\n4. Patient's foot ulcer located below malleoli and is between 1-20 cm2 in size on day 1\n5. Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:\n\n   i. Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30mmHg, OR ii. ABIs (Ankle brachial index) with results of ≥0.7 and ≤1.2, OR iii. Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg\n6. For female patients of childbearing potential, commitment to using a medically accepted means of birth control (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility) throughout study period and tests negative on a pregnancy test\n7. Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule (Grade 1 by Wagner's scale or Grade A-I by University of Texas Staging System), that has not shown signs of healing despite standard treatment\n8. Able and willing to wear an off-loading device or orthopedic shoe\n\nExclusion Criteria:\n\n1. Gangrene is present on any part of the affected foot\n2. Ulcer is of non-diabetic pathophysiology\n3. Patient's ulcer is over a Charcot deformity\n4. Ulcer total surface area \\> 20 cm2\n5. Osteomyelitis, cellulitis, or other evidence of infection\n6. Patient is currently being treated, or received treatment within one month prior, with chemotherapeutic agents, immunosuppressive agents, radiation therapy, or corticosteroids\n7. Patient has AIDS, HIV, or cardiac (ejection fraction less than 50% on 2D-ECHO; t-wave inversion on ECG), endocrine (hypothyroidism), disease, or present symptoms\u002Fcomplaints suggestive of gastrointestinal, neurological, or immune disease, that in the opinion of the Investigator, would make the patient an inappropriate candidate for this wound healing study.\n8. Patient with any of the below physiological parameters:\n\n   i. BP systolic \\>140 or \\\u003C90 mmHg or diastolic \\>90 or \\\u003C60mmHg ii. Pulse \\\u003C60 or \\>100bpm iii. Respiratory Rate \\\u003C9 and \\>20 bpm iv. Pulse Oximetry \\\u003C94% in room air v. Temp \\>100.4 degrees Fahrenheit vi. ALT and AST \\>2 times the upper limit of normal (ULN) vii. Abnormal bilirubin unless subject has Gilbert's viii. eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m2 by CKD-EPI ix. Platelet Count \\\u003C100,000 x. HbA1c: ≥8.5% xi. Hemoglobin: ≤10g\u002FdL\n9. Patients presenting with an ulcer probing to the bone (UT Grade IIIA-D).\n10. Patients with Wagner Grades 2-6 ulcers.\n11. Patient has had a previous lower extremity amputation.\n12. Received allograft, autograft, xenograft, or cellular therapy within 30 days of screening\n13. Female patients who are nursing, pregnant, or planning on becoming pregnant during the study period.\n14. Patient is unwilling or unable to comply with the postoperative visits necessary for data collection.\n15. Patients with known hypersensitivity to the components of the product or shipping medium.",{"count":122,"type":22},24,[124],"PHASE1","The objective of this study is to evaluate the safety and efficacy of VELGRAFT in patients with chronic diabetic foot ulcers, which have attained granulation tissue. VELGRAFT will be studied in conjunction with pest practices for diabetic foot ulcers. The Primary goal is to assess the safety of VELGRAFT to treat diabetic foot ulcers as compared to standard of care therapy. Secondary goals include the assessment of efficacy of VELGRAFT for healing diabetic foot ulcers compared to standard of care therapy",[30,127],"Granulation of Chronic Diabetic Wounds",[129,130],"Diabetic Foot Ulcers","VELGRAFT","2026-04-10",{"date":133,"type":39},"2026-04-15",{"date":135,"type":39},"2026-03-11",{"date":137,"type":22},"2026-10-13",{"name":139,"class":46},"Ayu, Inc.",{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":47},"100630482","phase-3-phase-iib-and-iii-safety-and-efficacy-study-chlorin-e6-gel-photodynamic-therapy-for-diabetic-foot-ulcers-100630482","NCT07488247","Phase IIb and III Safety and Efficacy Study Chlorin E6 Gel Photodynamic Therapy for Diabetic Foot Ulcers:","Single-Centre, Open-labeled, Randomized, Phase IIb and Phase III Clinical Studies to Evaluate the Safety, Tolerability, and Efficacy of Chlorin E6 (Gel Formation) as a Photosensitizing Agent for the Management of Diabetic Foot Ulcers With Photodynamic Therapy.","C6-PDT in DFU","Inclusion Criteria:\n\n1. Patients with diagnosis of Diabetes mellitus, with diabetic foot ulcer.\n2. Males and females subject of age 18 years and above.\n3. HbA1c of less than 12% and random blood sugars of less than 350 mg\u002Fdl.\n4. Vitally stable patient with no clinical signs of sepsis, a qSOFA (quick Sepsis-Related Organ Failure Assessment) score of \\\u003C2.\n5. ABI (Ankle Brachial Index) 0.7 to 1.2.\n6. Lower extremity ulcer of more than 30 days duration and less than 2 years duration.\n7. Total wound surface area between 0.5 to 20 cm.\n8. Deep wounds extending up to muscles (University of Texas Grade \\& Stage 1A, 1B, 2A \\& 2B) will be included.\n9. Patients giving written informed consent to participate in the study after a full understanding of the implications and constraints of the study protocol.\n10. Understand the content of the ICF, and voluntarily sign the ICF (If the participant is unable to sign the ICF on his\u002Fher own due to illiteracy, an impartial witness is needed).\n11. The subject can understand the research process and is willing and able to comply with all research proposals and other requirements of the study.\n12. Able to cooperate to complete the scheduled follow-ups till the end of the study\n\nExclusion Criteria:\n\n1. The vital signs or physical examination are clinically significantly abnormal as determined by the investigators in screening.\n2. A history of severe allergy (including drugs, vaccines, and foods) or allergy to any component of the experimental product.\n3. Subjects diagnosed with a serious disease, congenital malformation or chronic disease (including but not limited to serious: respiratory disease, cardiovascular disease, serious cerebrovascular disease, kidney disease, serious or uncontrollable diabetes, autoimmune disease, thrombocytopenic purpura, thalassemia, malignant tumor, hereditary allergic constitution, etc.) that may interfere with the conduct or completion of the study;\n4. Participating in or planning to participate in other clinical trials (drugs or vaccines) within 3 months prior to participating in this study;\n5. Other circumstances considered by the investigator as inappropriate to participate in the study.\n6. Vitally unstable patients with clinical signs and symptoms of sepsis, qSOFA score ≥2.\n7. More than 2 ulcers in the foot and leg.\n8. Deep wounds extending into bone (UoT Criteria any Grade stage C \\& D, Grade 3).\n9. Subjects with moderate to severe obstruction on ABI (\\\u003C0.7 or \\>1.3).\n10. Patients with HbA1c more than 12% and random blood sugar of more than 350 mg \u002Fdl.\n11. Subjects with evidence of cardiac disease or heart failure on ECG or echocardiography\n12. Patients with eGFR (Estimated Glomerular Filtration Rate) of less than 60 ml\u002Fmin\u002F1.73 m2.\n13. Pregnant or breast-feeding females or women of childbearing potential not using contraception.\n14. Hypersensitivity to investigational product\u002FChlorophyll-driven compounds.\n15. Diagnosed case of porphyria.\n16. Ophthalmological disease requiring slit-lamp examination or Yag-laser within the next 30 days or anti-VEGF therapy\u002Finjection.\n17. Patients who do not give written informed consent\n18. Subjects unable or unwilling to meet protocol requirements.\n19. Ulcer of non-diabetic etiology, such as venous, arterial, and burn wounds\n20. Ulcer is less than 3 cm in distance from any other ulcer on the same extremity.\n21. Ulcer presents with any of the following: osteomyelitis, exposed bone or gangrene.\n22. Ulcer surface area has decreased \\> 40% between screening and at randomization (visit 1) as assessed by the imaging system\n23. Has medically documented history of HIV\n24. Has severe protein malnutrition as defined by Serum Albumin \\\u003C 2.5 g\u002FdL.\n25. Has serum aspartate aminotransferase (AST, SGOT, GOT) or serum alanine aminotransferase (ALT, SGPT, GPT) levels greater than twice the upper limit of normal\n26. Has a medically documented or self-reported history, within the previous 12 months from date of screening visit, of alcohol or substance abuse.\n27. Has received previous treatment with the following during the 60 days prior to screening: immunosuppressive agents, radiation, chemotherapy, growth factors at the site of the Ulcer, split- or full-thickness skin graft at the site of the Ulcer, biologically active (or engineered) cellular or acellular product(s) at the site of the study ulcer, investigational drug or device\n28. Has ESR \\> 70 mm\u002Fh and CRP \\> 100 mg\u002FL at time of screening",{"count":149,"type":22},300,[151],"PHASE3","Protocol No. CHLORIN E6-IIB\u002FIII-01\u002FProtocol\u002F1.1 Title:Single-Centre, open-labeled, randomized, Phase IIb and Phase III clinical studies to evaluate the safety, tolerability, and efficacy of Chlorin E6 (Gel Formation) as a photosensitizing agent for the management of Diabetic Foot Ulcers with Photodynamic Therapy.\n\nSponsor Synverdis GmbH, Heidelberg, Germany. Study Phase: Phase IIb(Completed) \\& Phase III(Ongoing) Indication : Diabetic Foot Ulcers Study Population: This study will be conducted on diabetic participants who are 18 years of age or older, with a documented diagnosis of diabetes and foot ulceration that has been present for at least 4 weeks.\n\nSample Size of Phase IIb: 30 participants were enrolled. Phase III: 300 participants will be enrolled. Intervention Investigational Product: Chlorin E6 gel Specification: 1.0 mg\u002Fcm2 of Chlorin E6 1% W\u002FV in gel-form Formulation: Gel Storage and Transportation: Store and ship at 2\\~8°C, avoiding freezing.\n\nStandard of Care Treatment:\n\na. Surgical Intervention: Debridement of the wound will be performed for all the participants. b. Medical Intervention: i. Antibiotics: Targeted to aerobic Gram-positive cocci in mild to moderate infections.\n\n\\- Moxifloxacin\n\n* Linezolid\n* Co-Amoxiclav\n* Piperacillin + Tazobactam\n* Clindamycin\n\nDosage \\& Application Patients will receive 1.0 mg\u002Fcm2 of Chlorin E6 1% W\u002FV in gel form by local application on the ulcer. Approximately 30 minutes after the study drug administration, the ulcer will be washed thoroughly with normal saline. Then it will be illuminated with light at 660 to 670 nm from an approved laser source with a calculated light dose of 100 J\u002Fcm2. Light will be applied to the entire surface of the ulcer for 11 minutes. The wound will then be illuminated with UV light to assess the effectiveness of Photodynamic Therapy (PDT) and a further 11 minutes of therapy will be carried out if required.\n\nStudy Objectives Phase IIb:\n\nPrimary Objectives:\n\n1. To determine the safety and efficacy of a local Chlorin E6-mediated Photodynamic Therapy in patients with diabetic foot ulcers.\n2. To determine the effect of Chlorin E6 on the healing of diabetic foot ulcers defined by a reduction in size and depth of the ulcer.\n3. To compare the efficacy and healing rates of Diabetic foot ulcers with and without local Chlorin E6-mediated Photodynamic Therapy along with standard of care (SOC) management.\n4. To determine the eradication ratio of pathogenic bacteria through the synergistic effect of local Chlorin E6-mediated Photodynamic Therapy.\n\nPhase III:\n\nPrimary Objectives:\n\n1. To determine the safety and efficacy of a local Chlorin E6-mediated Photodynamic Therapy in patients with diabetic foot ulcers.\n2. To determine the effect of Chlorin E6 on the healing of diabetic foot ulcers defined by reduction in size and depth of ulcer.\n3. To compare the efficacy and rates of healing of Diabetic Foot Ulcer (DFU) with and without local Chlorin E6-mediated Photodynamic Therapy along with standard of care management.\n4. To determine the eradication ratio of pathogenic bacteria through the synergistic effect of local Chlorin E6-mediated Photodynamic Therapy.\n\nSecondary Objectives:\n\n1. To determine the rates of recurrence of diabetic foot ulcers during 6 months after local Chlorin E6-mediated Photodynamic Therapy.\n2. To determine the reduction in rates of amputation during 6 months after local Chlorin E6-mediated Photodynamic Therapy.\n\n   Study Endpoints Phase IIb:\n\n   Primary endpoints:\n\n   Safety:\n\n   • Solicited local and systemic AEs within 30 minutes and 7 days after product administration\u002Fapplication;\n\n   Secondary endpoints:\n\n   Safety:\n\n   • Unsolicited AEs within 28 days after product administration\u002Fapplication;\n\n   • SAEs throughout 3 months after product administration\u002Fapplication;\n\n   • Abnormal laboratory value analysis on Day 14 after product administration\u002Fapplication;\n\n   Efficacy:\n\n   • No growth on culture of wound base swab at 1 week after product administration\u002F application.\n   * Rate of healing \\> 15 % in 1 week or \\>50% in 1 month\n\n   Phase III:\n\n   Primary endpoints:\n\n   Safety:\n   * Solicited local and systemic AEs within 30 minutes and 7 days after product administration\u002Fapplication;\n\n   Secondary endpoints:\n\n   Safety:\n   * Unsolicited AEs within 28 days after product administration\u002Fapplication;\n   * SAEs throughout 6 months after product administration\u002Fapplication;\n   * Abnormal laboratory value analysis on Day 14 after product administration\u002Fapplication;\n\n   Efficacy:\n   * No growth on culture of wound base swab at 1 week after product administration\u002F application.\n   * Rate of healing \\> 15 % in 1 week or \\>50% in 1 month.\n\n   Phase IIB of this trial is completed and screening of Phase III is started on 31-Mar-2026.",[30],[28,29,155,156,157,158,159],"PDT","Photodynamic Therapy","Chlorin E6","Phase IIB of Chlorin E6","Chlorin E6 Gel","2026-04-01",{"date":162,"type":39},"2026-04-07",{"date":164,"type":39},"2026-04-02",{"date":166,"type":22},"2027-11",{"name":168,"class":79},"United Medical and Dental College",{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":23,"phases":178,"briefSummary":179,"conditions":180,"keywords":181,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":192},"100601874","a-prospective-clinical-study-to-evaluate-the-effectiveness-and-safety-of-xcell-amnio-matrixtm-xam-in-the-management-of-chronic-non-healing-dfus-100601874","NCT07116174","A Prospective Clinical Study to Evaluate the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) in the Management of Chronic Non-healing DFUs","A Prospective, Multi-center, Randomized Controlled Clinical Trial Evaluating the Effectiveness and Safety of Xcell Amnio MatrixTM (XAM) as Adjunct to Standard of Care (SOC) Therapy Compared to SOC Alone in the Management of Diabetic Foot Ulcers","Inclusion Criteria:\n\nSubjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:\n\n1. Subject is 18 years of age or older.\n2. Subject has diabetes mellitus (Type 1 or Type 2), requiring insulin or oral\u002Finjectable medications to control blood glucose levels\n3. Glycosylated hemoglobin (HbA1c) level is \\\u003C12%\n\n   Note: Prior documented HbA1c within 12 weeks of Screening is acceptable.\n4. Duration of ulcer is ≥ 4 weeks but ≤ 1 year, unresponsive to SOC\n5. Ulcer area is ≥ 1.5cm2 and ≤ 20cm2 and with a clean, granulating base with minimal adherent slough at the Baseline Visit\n6. Ulcer location is at or below the ankle (malleolus)\n7. Subject is amenable to use of off-loading, as needed for plantar ulcer\n8. Ulcer extends through the full thickness of the skin but not down to muscle, tendon, or bone\n9. Subject is at least 12 weeks post lower extremity revascularization procedure, if one has been performed.\n10. Subject is in general good health, with no clinically significant medical conditions or abnormalities that, in the opinion of the Investigator, would interfere with study participation, the assessment of study endpoints, or pose additional risk to the subject.\n11. Adequate circulation to the affected lower extremities as demonstrated by one of the following within 12 weeks of screening:\n\n    1. Dorsum transcutaneous oxygen measurement (TCOM) ≥ 30 mmHg,\n    2. Skin perfusion pressure (SPP) measurement ≥ 30 mmHg,\n    3. Ankle-Brachial Index (ABI) ≥0.7 and ≤1.2, OR\n    4. Toe-Brachial Index (TBI) ≥ 0.6\n12. Subject is willing to use an acceptable method of contraception throughout the duration of the trial, if of childbearing potential.\n\n    Acceptable methods of contraception include abstinence, female subject\u002Fpartner's use of hormonal contraceptive (oral, patch, injectable, depot or vaginal) in conjunction with a barrier method (e.g., diaphragm, cervical cap, condom, spermicide or sponge), or female subject\u002Fpartner's use of an implantable device (implantable rod or intrauterine device).\n\n    Female subject\u002Fpartners of non-childbearing potential are defined as surgically sterile (e.g., bilateral tubal ligation, hysterectomy) or two years postmenopausal at time of screening.\n\n    All male subjects (excluding men who have been sterilized) with female partners of child-bearing potential must agree to consistently and correctly use a condom for the duration of the study. In addition, subjects may not donate sperm for the same time period.\n13. Subject is able to read, understand and sign the informed consent form (ICF).\n14. Subject is available and willing to complete all study assessments and can comply with standard of care (debridement, dressing changes etc.) as applicable.\n\nExclusion Criteria:\n\nSubjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:\n\n1. Clinical evidence of ongoing infection and\u002For receipt of IV, oral, or topical antimicrobials.\n2. Wheelchair bound or bed-ridden (ambulatory with assistance is acceptable).\n3. Ulceration at the site of amputation.\n4. Undergoing renal dialysis.\n5. Known or suspected malignancy in the target ulcer, or a history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer).\n6. Documented history of osteomyelitis at the target ulcer location within 6 months of screening.\n7. History of radiation at the ulcer site.\n8. New York Heart Association Class III or IV congestive heart failure or uncontrolled cardiac dysrhythmia.\n9. Diagnosis of autoimmune disease(s) (rheumatoid arthritis, lupus, psoriasis, Sjogren's syndrome) or arthritis requiring corticosteroid treatment.\n10. Subject has received in the past 4 weeks or is scheduled to receive any of following medication or therapies during the course of the study:\n\n    1. Immunosuppressants (including chronic systemic corticosteroids or application of topical steroids to the ulcer surface)\n    2. Cytotoxic chemotherapy\n    3. Growth hormone\n    4. Oral or systemic antifungal or antituberculosis treatment\n    5. Use of any investigational drug(s) or therapeutic device(s)\n11. Target ulcer(s) previously treated with negative pressure, hyperbaric oxygen, or tissue engineered materials (e.g., Apligraf®, EpiFix® or Dermagraft®) or other scaffold materials (e.g., Oasis, Matristem) within 4 weeks prior to screening.\n12. Target ulcer(s) anticipated to require negative pressure wound therapy or hyperbaric oxygen at any time during the study.\n13. Healing of target ulcer is observed to be ≥35% at the end of the Run-in Period (between Screening and Baseline Visits)\n14. Subject is pregnant or breastfeeding.\n15. Presence of any other condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.\n16. Active Charcot foot (stable chronic Charcot foot is not exclusionary).\n17. Ulcers on toes 2, 3, 4, and\u002For 5 only (ulcer on plantar surface of the great toe only is not exclusionary).",{"count":177,"type":22},135,[58],"The goal of this clinical trial is to evaluate the clinical outcomes of Diabetic Foot Ulcers (DFUs) treated with a weekly application of Xcell Amnio MatrixTM (XAM) as adjunct to standard of care (SOC) compared to SOC alone in male and female over the age of 18 years old. The main question it aims to answer is:\n\nWhat is the proportion of subjects with complete wound closure during the 12 weeks of the treatment phase?\n\nParticipants:\n\n* Will be screened and re-screened after 2 weeks to be assessed whether they meet the eligibility criteria\n* Eligible subjects will receive study product application, and for 12 weeks will return to the clinic once every 7 days (±3 days) for treatment visits\n* Subjects who complete the treatment will be followed up after 2 weeks",[30],[29],"2026-03-30",{"date":184,"type":39},"2026-03-31",{"date":186,"type":39},"2025-08-15",{"date":188,"type":22},"2026-08-15",{"name":190,"class":191},"New Horizon Medical Solutions","NETWORK",3,{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":23,"phases":202,"briefSummary":203,"conditions":204,"keywords":205,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":224,"leadSponsor":226,"locationsCount":47},"100615289","evaluating-the-efficacy-of-foundationdrs-solo-in-addition-to-standard-of-care-for-the-treatment-of-non-healing-diabetic-foot-ulcers-100615289","NCT07290673","Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers","A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Foundation DRS Solo as an Adjunct to Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers.","Inclusion Criteria:\n\n1. 1\\. Subjects must be at least 18 years of age or older.\n2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus requiring treatment with oral medications and\u002For insulin replacement therapy.\n3. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement prior to randomization at treatment visit 1 (TV1).\n4. The target ulcer must have been present for a minimum of 4 weeks and is unresponsive (defined by less than 50% wound area reduction) to standard wound care.\n5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.\n6. The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below either malleoli.\n7. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. ABI between 0.7 and ≤ 1.3;\n   2. TBI ≥ 0.6;\n   3. TCOM ≥ 40 mmHg;\n   4. PVR: biphasic;\n   5. skin perfusion pressure (SPP) ≥ 30 mmHg.\n8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n9. The index ulcer has been offloaded with protocol defined offloading device for at least 14 days prior to randomization (i.e. Screening through TV1\u002FRandomization).\n10. The potential subject must consent to using the prescribed offloading method for the duration of the study.\n11. The potential subject must agree to attend the weekly study visits required by the protocol.\n12. The potential subject must be willing and able to participate in the informed consent process.\n13. Index ulcer and\u002For index ulcer limb may have had prior infection(s), but must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1 (Appendix L).\n14. The index ulcer has a clean base and is free from necrotic debris at time of placement of product \u002F treatment.\n15. Negative pregnancy test for females of childbearing potential (e.g., not post-menopausal for at least one yar or surgically sterile). Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.\n\nExclusion Criteria:\n\n1. The target ulcer has been present for more than 52 weeks.\n2. The ulcer includes exposed tendon or bone.\n3. The potential subject is known to have a life expectancy of \\\u003C 6 months.\n4. The potential subject's target ulcer is not secondary to diabetes.\n5. The target ulcer is infected or has cellulitis in the surrounding skin.\n6. There is evidence of osteomyelitis complicating the target ulcer.\n7. The potential subject has an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n8. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.\n9. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n10. The potential subject has a previous partial amputation on the affected foot that resulted in a deformity impeding proper offloading of the target ulcer.\n11. A potential subject must be excluded if either of the following conditions are met:\n\nCondition A (Overall 4-week reduction)\n\nThe surface are of the target ulcer has decreased by more than 50% over the 4 weeks prior to Treatment Visit 1, which includes:\n\nThe historical run-in period, and\n\nThe 2-week Screening Phase.\n\nOR\n\nCondition B (Sequential reductions across both phases)\n\nBoth of the following are true:\n\n1. During the historical run-in period (the 2-weeks prior to the Screening Visit):\n\n   The target ulcer surface area decreases by more than 25%.\n2. During the active 2-week Screening Phase (from Screening Visit 1 \\[SV1\\] to Treatment Visit 1 \\[TV1\\]):\n\nThe target ulcer surface area decreases by an additional 25% or more.\n\n12\\. The surface area of the potential subject's target ulcer has reduced in size by more than 50% in the 4 weeks prior to Treatment Visit 1 (i.e. 2-week historical run-in and 2-week screening phase).\n\n13\\. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n\n14\\. The potential subject has an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer.\n\n15\\. The potential subject is pregnant or considering becoming pregnant within the next 6 months.\n\n16\\. The potential subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.\n\n17\\. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.\n\n18\\. The potential subject has, in the opinion of the investigator, a medical or psychological condition that may interfere with study assessments.\n\n19\\. The potential subject is treated with hyperbaric oxygen therapy or cellular, acellular and matrix-like products (CAMPS) in the 30 days prior to the initial screening visit .\n\n20\\. The potential subject has a score of less than 17 and is considered malnourished according to the Mini Nutritional Assessment (MNA).\n\n21\\. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.\n\n22\\. Subject has ulcers that are completely necrotic or fibrotic tissue. 23. Subject currently being treated for an active malignant disease or subjects with history of malignancy within the ulcer.\n\n24\\. Known contraindications to or known allergies to any of the Foundation DRS Solo components.\n\n25\\. Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization (TV1).\n\n26\\. Index ulcer and\u002For index limb with presence of gangrene or unstable ischemia at the initial screening visit (SV1).\n\n27\\. Index ulcer in the opinion of the Principal Investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.\n\n28\\. Any clinically significant finding, in the judgment of the Principal Investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.",{"count":201,"type":22},124,[58],"The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients.\n\nThe main question that this study aims to answer is:\n\nDoes FoundationDRS Solo, when used in conjunction with standard of care wound management techniques, result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment.\n\nOne ulcer on each participant's foot will receive weekly applications of 1) FoundationDRS Solo and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.",[30],[206,102,207,208,103,209,210,211,212,213,214,215,216,217,218,219],"Diabetes","Allograft","Scaffold","Advanced Wound Care","Comparative Effectiveness","Lower Extremity Ulcer","Time to heal","Treatment","Diabetes Complication","Skin Ulcer","Neuropathy","Peripheral artery disease","Ischemia","Wagner Grade","2026-03-05",{"date":222,"type":39},"2026-03-09",{"date":160,"type":22},{"date":225,"type":22},"2027-12-31",{"name":227,"class":46},"Samaritan Biologics",{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":235,"targetDuration":237,"studyType":238,"phases":4,"briefSummary":239,"conditions":240,"keywords":244,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":47},"100627724","ai-based-diabetic-foot-recurrence-cohort-100627724","NCT07452354","AI-Based Diabetic Foot Recurrence Cohort","Development and Validation of an AI-Based Wound Alert System With a Home-Based Management Model for a Diabetic Foot Recurrence Cohort","Inclusion Criteria:\n\n* The patient must be aged 18 years or older; have a confirmed diagnosis of type 1 or type 2 diabetes mellitus according to the World Health Organization criteria; the wound etiology attributable to diabetic foot ulcers, with complete wound healing post-treatment defined as a dry wound devoid of exudate, complete epithelialization of both the wound bed and margins, absence of surrounding erythema or edema, and sufficient tensile strength to withstand pressure without dehiscence; voluntary participation in this study with provision of written informed consent.\n\nExclusion Criteria:\n\n* Inability of the patient to cooperate or presence of psychiatric disorders; At the investigator's discretion, the subject is deemed unsuitable for this study or unable to comply with the study requirements.",{"count":236,"type":22},200,"3 Months","OBSERVATIONAL","Diabetic foot ulcer (DFU) is a major adverse outcome of diabetes, which itself is one of the most significant chronic diseases. The recurrence of DFU involves multiple risk factors, including altered foot loading patterns, patient compliance, family care capacity, blood glucose monitoring, degree of ischemia, and systemic disease control. Early identification of recurrence signs and timely follow-up interventions are crucial for improving prognosis, reducing disability rates, and lowering healthcare costs. However, traditional follow-up systems lack individualized strategies-such as risk stratification, inflexible follow-up intervals, and insufficient compliance management-often resulting in suboptimal outcomes. High-risk patients prone to recurrence may not be followed up frequently enough for early detection, while low-risk patients may undergo unnecessary visits, increasing burdens on both patients and healthcare providers. This inefficiency contributes significantly to the persistently high rates of disability and mortality among recurrent DFU patients.\n\nEstablishing an individualized follow-up strategy for DFU, supported by advanced technology to address core bottlenecks such as delayed recurrence warnings and inadequate home-based management, represents an effective technical pathway to tackle these issues.\n\nOur center proposes to develop a dedicated DFU cohort with comprehensive active follow-up and a multimodal database encompassing well-defined indicators. We aim to explore a high-risk foot grading system for preventing DFU recurrence and design targeted follow-up protocols. By leveraging AI technology, we intend to build a wound warning system capable of identifying DFU recurrence. Furthermore, we seek to establish a telemedicine and AI-assisted, patient-centered home-based self-management framework for early warning and prevention of DFU recurrence.",[30,241,242,243],"Diabete Mellitus","Diabetic Foot Ulcer Treatment","Artificial Intelligence (AI) in Diagnosis",[28,242,241,245,243],"Reccurrence","2026-02-28",{"date":220,"type":39},{"date":249,"type":22},"2026-03-15",{"date":251,"type":22},"2028-12-31",{"name":253,"class":79},"Peking University Third Hospital",{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":238,"phases":4,"briefSummary":263,"conditions":264,"keywords":266,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":4},"100621787","evaluation-of-the-safety-and-efficacy-of-dehydrated-human-placenta-tissue-dhpt-for-wound-healing-100621787","NCT07375160","Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing","A Retrospective, Real World Evidence (RWE) Trial to Evaluate the Safety and Efficacy of a Dehydrated Human Placenta Tissue (dHPT) for Wound Healing","RETRO-PLAST","Inclusion Criteria:\n\n* 18 years of age or older.\n* Wound treated with Cellution Biologics AmchoPlast, a dehydrated human placental tissue (dHPT).\n* Wound present for greater than or equal to 30 days prior to treatment with dHPT.\n* Wound is not infected.\n* Wound surface area is greater than 1cm2 at initial assessment.\n* Clinical documentation of wound treatment.\n\nExclusion Criteria:\n\n* AmchoPlast dHPT product was not applied to wound.\n* HbA1C \\>12%.\n* Presence of active osteomyelitis.\n* Concurrent treatment for malignant disease.\n* Use of other advanced biologics during treatment period.",{"count":149,"type":22},"The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.",[30,265,92],"Venous Leg Ulcer (VLU)",[96,267,268,207,269],"Leg Wound","Amniotic","Placenta","2026-02-27",{"date":272,"type":39},"2026-03-03",{"date":274,"type":22},"2026-04",{"date":276,"type":22},"2026-12",{"name":278,"class":46},"Cellution Biologics",{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":4},"100627541","modified-platform-trial-assessing-multiple-umbilical-cord-based-camps-and-soc-v-soc-alone-in-the-treatment-of-hard-to-heal-dfus-100627541","NCT07449975","Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal DFUs","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Umbilical CORD-Based Skin Substitutes and Standard of Care Versus Standard of Care Alone in the Treatment of Hard-to-Heal Diabetic Foot Ulcers","CORDSTIM-DFU","Inclusion Criteria:\n\n1. At least 18 years of age or older.\n2. Diagnosis of type 1 or 2 Diabetes mellitus.\n3. At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the MolecuLight® Imaging Device.\n4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.\n5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.\n6. The target ulcer must be full thickness without exposed bone.\n7. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable: a. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3; b. Toe-Brachial Index (TBI) ≥ 0.6; c. Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg; d. Pulse Volume Resistance (PVR): biphasic.\n8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.\n10. The potential subject must consent to using the prescribed offloading method for the duration of the study.\n11. The potential subject must agree to attend the weekly study visits required by the protocol.\n12. The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n1. The potential subject is known to have a life expectancy of \\\u003C 6 months.\n2. The potential subject's target ulcer is not secondary to diabetes.\n3. The target ulcer is infected or there is cellulitis in the surrounding skin.\n4. The target ulcer exposes tendon or bone.\n5. There is evidence of osteomyelitis complicating the target ulcer.\n6. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n7. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n8. The potential subject is taking hydroxyurea.\n9. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n10. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n11. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n12. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). MolecuLight Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n13. The surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.\n14. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n15. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.\n16. The potential subject has end stage renal disease requiring dialysis.\n17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.\n18. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n19. The target ulcer was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit. 20. The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutrition Assessment.",{"count":288,"type":22},272,[58],"The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products\u002Fskin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.",[30,34,102,292],"Foot Ulcer",[294,295,296],"Cellular, Acellular, Matrix-like Product (CAMP)","Cellular and\u002For Tissue Product (CTP)","Dehydrated Human Umbilical Cord (dHUC)","2026-02-26",{"date":299,"type":39},"2026-03-04",{"date":301,"type":22},"2026-07",{"date":303,"type":22},"2029-09",{"name":305,"class":46},"StimLabs",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":315,"briefSummary":316,"conditions":317,"keywords":318,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":325,"locationsCount":326},"100550635","modified-platform-trial-assessing-multiple-camps-and-soc-vs-soc-alone-in-the-treatment-of-hard-to-heal-dfus-100550635","NCT06449638","Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Placental-Based Skin Substitutes and Standard of Care Versus SOC Alone in the Treatment of Hard-to-Heal Diabetic Foot Ulcers","CAMPSTIM","Inclusion Criteria:\n\n1. At least 18 years of age or older.\n2. Diagnosis of type 1 or 2 Diabetes mellitus.\n3. At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement with the MolecuLight® Imaging Device.\n4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.\n5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.\n6. The target ulcer must be full thickness without exposed bone.\n7. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3;\n   2. Toe-Brachial Index (TBI) ≥ 0.6;\n   3. Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg;\n   4. Pulse Volume Resistance (PVR): biphasic.\n8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.\n10. The potential subject must consent to using the prescribed offloading method for the duration of the study.\n11. The potential subject must agree to attend the weekly study visits required by the protocol.\n12. The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n1. The potential subject is known to have a life expectancy of \\\u003C 6 months.\n2. The potential subject's target ulcer is not secondary to diabetes.\n3. The target ulcer is infected or there is cellulitis in the surrounding skin.\n4. The target ulcer exposes tendon or bone.\n5. There is evidence of osteomyelitis complicating the target ulcer.\n6. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n7. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n8. The potential subject is taking hydroxyurea.\n9. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n10. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n11. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n12. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). MolecuLight Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n13. The surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.\n14. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n15. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.\n16. The potential subject has end stage renal disease requiring dialysis.\n17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.\n18. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n19. The target ulcer was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n20. The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutrition Assessment.",{"count":288,"type":22},[58],"The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products\u002Fskin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.",[30,34,102,292],[294,295,319],"Dehydrated Complete Human Placental Membrane (dCHPM)",{"date":321,"type":39},"2026-03-02",{"date":323,"type":39},"2024-07-16",{"date":276,"type":22},{"name":305,"class":46},5,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":334,"maxAge":335,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":4},"100621646","vinegar-vs-normal-saline-dressing-for-diabetic-foot-ulcers-100621646","NCT07373327","Vinegar vs Normal Saline Dressing for Diabetic Foot Ulcers","A Randomized Clinical Trial to Compare the Efficacy of Vinegar Dressing Versus Normal Saline Dressing in the Treatment of Diabetic Foot Ulcers","Inclusion Criteria:\n\n* Age: 20 to 65 years.\n* Gender: Both male and female participants are included.\n* Condition: Patients with Grade 3 and 4 infected diabetic foot ulcers (DFU) according to the Wagner classification.\n\nExclusion Criteria:\n\n* Wagner Grades 1, 2, 5, and 6 diabetic foot ulcers.\n* History of Radiotherapy.\n* History of Chemotherapy.\n* Use of Steroids.\n* Use of Immunosuppressive drugs.\n* Allergy to vinegar.","20 Years","65 Years",{"count":337,"type":22},84,[58],"This study is investigating the effectiveness of two different types of wound dressings in treating diabetic foot ulcers (DFUs), a common complication of diabetes that can be difficult to heal. The study will compare the use of vinegar dressings to normal saline (saltwater) dressings to see which one helps heal the wound faster and more effectively.\n\nPeople with diabetic foot ulcers often struggle with infections and slow healing. The goal of this study is to determine if vinegar, a simple and affordable treatment, works better than saline in improving wound healing and reducing infections. The study will measure how quickly the wound heals, how much dead tissue is removed, and whether the bacteria in the wound disappear.\n\nThis study will involve patients with infected diabetic foot ulcers. Participants will be randomly assigned to receive either vinegar or saline dressing. The results will help determine the best and most cost-effective treatment for diabetic foot ulcers, potentially making it easier for patients to access better care.",[30],"2026-01-19",{"date":343,"type":39},"2026-01-28",{"date":345,"type":22},"2026-02-04",{"date":347,"type":22},"2026-08-01",{"name":349,"class":79},"University of Health Sciences Lahore",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":357,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":361,"conditions":362,"keywords":363,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":375},"100606233","phase-4-a-non-randomized-open-label-clinical-trial-evaluating-dermabind-tl-100606233","NCT07172893","A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL","A Non-Randomized Open Label Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of DermaBind TL, a Placental Membrane Allograft Intended for Use in the Management of Non-Healing Ulcers","Inclusion Criteria:\n\n* 1\\. Be an adult between 18 and 80 years of age at the time of consent 2. Presence of a DFU, Wagner Grade 1 or 2 (see Appendix A for definitions) on the plantar, lateral or dorsal aspect of the foot, extending through the dermis provided it is below the medial aspect of the malleolus.\n\n  3\\. Subjects must have a diagnosis of Type I or Type II diabetes mellitus (DM) as defined by the American Diabetes Association\n  1. for Type I DM, have been on a stable anti-diabetic treatment for at least 30 days before the baseline visit, or\n  2. for Type II DM, must have been on a stable anti-diabetic medication for at least 30 days, or if diet-controlled only, must have been on stable diet-control for at least 6 months.\n\n     4\\. For Type I and Type II DM, A1C must be equal or \\\u003C10% in the last 30 days, or confirmed during the screening period (SV1 up to TV1) 5. Have a single target ulcer 6. If other DFU wounds are present on the same foot, they must be more than 2 cm distant from the index ulcer. \\[NOTE: If two or more DFUs are present with the same grade on the same foot, the index ulcer is the largest ulcer and the only one evaluated in the study.\\] 7. Have a wound with an area greater than 1cm2 and less than 25 cm2 and does not probe to bone 8. Index ulcer has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.\n\n     9\\. Index ulcer must be a DFU with a Wagner Grade of 1 or 2. 10. Have an absence of infection based on the Infectious Disease Society of America criteria and as evidenced by radiographic evidence (X-ray, CT or MRI scan) performed during the 14 Screening Period (SV1-TV1). Radiological evidence must be completed, resulted and confirmed by the treating study physician prior to application of study graft to index ulcer.\n\n     11\\. Have adequate circulation to the affected lower extremity confirmed during the screening period, defined as at least one of these criteria:\n\n  \u003C!-- -->\n\n  1. TCOM ≥30 mmHg\n  2. ABI between 0.7 and 1.3\n  3. SPP \\>30 mmHg\n  4. As an alternative, Arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle on the extremity the index ulcer is located.\n\n     12\\. Have the ability to comply with protocol defined off-loading to the index ulcer and dressing change requirements 13. Patient is a non-tobacco user, including all forms of nicotine delivery (e.g., cigarettes, cigars, pipes, vaping devices, smokeless tobacco or nicotine patch) for a minimum of 4 weeks prior to the initial application of study graft. Verbal confirmation by subject is acceptable.\n\n     14\\. Have the ability to understand the requirements of the study and to give informed consent 15. Have a life expectancy of greater than 6 months 16. Have failed conservative wound care treatment of the index ulcer for at least of 4 weeks 17. Patient will not require negative pressure therapy to the index ulcer, antimicrobial dressings, hyperbaric oxygen therapy to the index ulcer during the study period.\n\n     18\\. Patient has not had radiation to the index ulcer site. 19. The index ulcer has a clean base, free of necrotic debris and infection at time of placement of treatment product.\n\n     20\\. The index ulcer has been off-loaded, per protocol requirements, with a CAM boot (Foot Defender®) or TCC for a minimum of 14 days (+3 days) following SV1.\n\n     21\\. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests at various timepoints during study participation.\n\n     Exclusion Criteria:\n* 1\\. Pregnant or lactating 2. Less than 18 years of age 3. Has continued tobacco use 4. Have a wound that decreased in size ≥30% between the Screening and Treatment Visits 5. Wound is showing signs of healing and that improvement is likely to continue without treatment (increased granulation, epithelization, decrease in size ≥ 30% reduction in wound surface area).\n\n  6\\. Circulating hemoglobin A1c exceeding 10% within 30 days of the Screening Visit 7. Serum creatinine concentrations of 3.0 mg\u002FdL or greater within 30 days prior to screening 8. The wound has been treated with biomedical or topical growth factors within the previous 30 days before the screening visit 9. Need for any additional concomitant dressing material other than the ones approved for this study 10. Osteomyelitis or bone infection of the affected foot as verified by x-ray or other radiographic modality within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).\n\n  11\\. The inability to tolerate off-loading (a surgical shoe, removable cast walker or a total contact cast) 12. Have a known or suspected disease of the immune system 13. Have an active or untreated malignancy or active, uncontrolled connective tissue disease 14. Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.\n\n  15\\. At the index ulcer site, presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement 16. Had undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the baseline visit 17. Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening 18. Uncontrolled edema, lymphedema or venous HTN in the limb of the index ulcer 19. Undergone treatment to the index ulcer with a living skin equivalent within the last 4 weeks before screening 20. Undergone treatment to the index ulcer with a placental-derived allograft within the last 4 weeks before screening 21. Has the presence of any condition that in the opinion of the investigator places the subject at undue risk or potentially jeopardizes the quality of the data to be generated 22. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.\n\n  23\\. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.\n\n  24\\. Subjects with a previous diagnosis of HIV or Hepatitis C, regardless of current status .","80 Years",{"count":359,"type":22},150,[25],"The purpose of this clinical evaluation is to collect patient outcome data and evaluate the efficacy, safety and tolerability of HealthTech DermaBind TL™ in patients with chronic non-healing wounds in patients with chronic non-healing ulcers.",[30,265],[364,28,94,365],"Placental allograft","DermaBind TL","2025-12-22",{"date":368,"type":39},"2025-12-23",{"date":370,"type":39},"2025-12-10",{"date":372,"type":22},"2027-05-21",{"name":374,"class":46},"HealthTech Wound Care",10,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":18,"minAge":383,"maxAge":357,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":390,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":405},"100601928","matrion-decellularized-placental-membrane-versus-conventional-wound-management-in-subjects-with-diabetic-foot-ulcers-100601928","NCT07116876","Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers","An Open-Label Trial to Assess the Clinical Effectiveness of Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers","Inclusion Criteria:\n\nTo be considered eligible to participate in this study, a subject must meet the inclusion criteria listed below:\n\n1. Be male or female and aged between 21 and 80 years at the time of informed consent\n2. Have a diagnosis of Type I or Type II diabetes as defined by the American Diabetes Association and have been on a stable anti-diabetic treatment regimen for at least 30 days before the baseline visit.\n3. Have full-thickness wound of the lower extremity, below the ankle\n4. Have a single target ulcer\n5. Have a wound with an area greater than or equal to 1cm2 and less than 25 cm2 with a depth less than or equal to 9 mm\n6. Have a diabetic foot ulcer that has been present for at least 30 days with a Wagner Classification Grade 1 or 2:\n\n   * Grade 1: superficial diabetic ulcer involving the full skin thickness but not underlying tissues\n   * Grade 2: ulcer extension involving ligament, tendon, joint capsule, or fascia, without presence of abscess or osteomyelitis\n7. Have an absence of infection based on Infectious Disease Society of America criteria (assessed at BOTH Screening\u002FVisit 1 and Baseline\u002FVisit 2)\n8. Have an adequate circulation to the affected lower extremity, defined as at least one of the criteria within the previous 60 days:\n\n   * Transcutaneous oxygen measurement at the dorsum of the foot greater or equal to 30 mm Hg\n   * Ankle-brachial index (ABI) ranging from 0.8 to 1.2\n   * At least biphasic Doppler arterial waveforms at the dorsalis pedis and posterior tibial arteries\n9. Have the ability to comply with off-loading and dressing change requirements\n10. Have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and agree to abide by the study restrictions and return to the site for the required assessments\n11. Have provided written authorization for use and disclosure of protected health information\n12. Have a life expectancy of greater than 6 months\n\nExclusion Criteria:\n\nTo be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:\n\n1. Be pregnant or lactating\n2. Subjects with a target wound \\\u003C30 days old at Screening whose wound area has decreased in size ≥50% between the Screening and Baseline Visits (assessed at Baseline\u002FVisit 2)\n3. Have a circulating hemoglobin A1c exceeding 12% within 90 days of the Screening Visit (assessed at Screening\u002FVisit 1 for subjects with labs collected \\\u003C30 days of screening; assessed at Baseline\u002FVisit 2 for subjects with labs collected at screening)\n4. Have a serum creatinine concentration of 3.0 mg\u002FdL or greater within 30 days prior to screening (assessed at Screening\u002FVisit 1 for subjects with labs collected \\\u003C30 days of screening; assessed at Baseline\u002FVisit 2 for subjects with labs collected at screening)\n5. Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin\n6. Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol\n7. Have the wound treated with biomedical or topical growth factors within the previous 30 days before the Screening Visit\n8. Need for any additional concomitant dressing material other than the ones approved for this study\n9. Have clinical signs of an infection at the study ulcer site (assessed at BOTH Screening\u002FVisit 1 and Baseline\u002FVisit 2)\n10. Have the inability to tolerate an off-loading boot\n11. Have a known or suspected disease of the immune system\n12. Have an active or untreated malignancy or active, uncontrolled connective tissue disease\n13. Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the Baseline Visit\n14. Have presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement (assessed at Baseline\u002FVisit 2)\n15. Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the Baseline Visit\n16. Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening (assessed at Screening\u002FVisit 1 if subject had labs collected \\\u003C30 days of screening; assessed at Baseline\u002FVisit 2 if subject had labs collected at screening)\n17. Have active Charcot disease\n18. Have undergone treatment with a living skin equivalent within the last 4 weeks before screening\n19. Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot\n20. Have the presence of any condition that in the opinion of the investigator places the subject at undue risk or potentially jeopardizes the quality of the data to be generated","21 Years",{"count":385,"type":22},120,[58],"This study will evaluate Matrion™ (LifeNet Health, Inc., Virginia Beach, VA), a placental membrane product, as a treatment for diabetic foot ulcers compared to conventional wound care. Matrion is derived from donated human birth tissue and includes both the amniotic and chorionic layers, along with the trophoblast layer. It is minimally processed using a proprietary decellularization method and terminally sterilized to ensure the membrane is acellular and sterile, making it suitable for surgical applications.",[30,389],"Lower Extremity",[67,391,392,393,394,395,396],"placental membrane","lower extremity wound","decellularized placental membrane","foot diseases","foot ulcer","conventional wound management","2025-12-09",{"date":370,"type":39},{"date":400,"type":39},"2025-06-26",{"date":402,"type":22},"2026-06",{"name":404,"class":46},"LifeNet Health",18,{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":413,"targetDuration":414,"studyType":238,"phases":4,"briefSummary":415,"conditions":416,"keywords":417,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":426,"locationsCount":47},"100614239","ai-wound-alert--home-management-for-recurrent-dfu-100614239","NCT07277010","AI Wound Alert & Home Management for Recurrent DFU","Building an Artificial Intelligence-Driven Early Warning System and Home Management Protocol for a Diabetic Foot Ulcer Recurrence Cohort","Inclusion Criteria:\n\n* A diagnosis of type 1 or type 2 diabetes in accordance with the definitions set by the World Health Organization；\n* The wound was caused by diabetic foot\\*. After treatment, the wound healed. The criteria for successful healing were as follows: the wound was dry with no exudate; the wound bed and edges were completely epithelialized; there were no signs of redness or swelling in the surrounding area; and the wound had sufficient tensile strength to withstand pressure without cracking；\n* Voluntarily participated in this study and signed the informed consent form.\n\nExclusion Criteria:\n\n* The patient is unable to cooperate or has a mental disorder；\n* At the discretion of the researchers, the subject is not suitable for this study or is unable to comply with the requirements of this study.",{"count":236,"type":22},"1 Year","Diabetes is one of the major chronic diseases, and diabetic foot ulcer (DFU) is a significant adverse prognosis of diabetes. The recurrence of DFU after healing involves multiple risk factors, such as changes in foot loading patterns, patient compliance, family care capacity, blood glucose monitoring, the degree of ischemia, and control of systemic diseases. Early identification of signs of DFU recurrence and timely follow-up interventions are crucial for improving prognosis, reducing disability rates, and lowering healthcare costs. However, traditional follow-up systems lack individualized strategies (e.g., insufficient risk stratification, rigid follow-up intervals, inadequate compliance management), often resulting in low follow-up efficacy. High-risk patients prone to recurrence may not receive frequent enough follow-ups for early detection, while low-risk patients unlikely to recur may undergo multiple unnecessary visits, increasing the burden on both patients and healthcare providers. This inefficiency is a key reason for the persistently high rates of disability and mortality among patients with recurrent DFU. Establishing individualized follow-up strategies for DFU, leveraging advanced technologies to address core bottlenecks such as delayed recurrence warnings and insufficient home management, represents an effective technical approach to solving these problems.\n\nOur center aims to establish and refine a specialized cohort for active DFU follow-up, along with a multimodal database with comprehensive indicators. We plan to explore a high-risk foot grading system for preventing DFU recurrence and develop targeted follow-up protocols. Using AI technology, we will create a wound alert system capable of identifying DFU recurrence and explore a remote healthcare and AI-assisted prevention and control system for DFU recurrence, centered on patient self-management at home.",[30],[67,418,419],"recurrent","precaution","2025-11-30",{"date":422,"type":39},"2025-12-11",{"date":424,"type":22},"2026-01-01",{"date":251,"type":22},{"name":253,"class":79},{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":23,"phases":437,"briefSummary":438,"conditions":439,"keywords":441,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":454},"100596538","camp-rwe-trial-amnion-grafts-for-healing-hard-to-heal-ulcers-in-rw-populations-100596538","NCT07046767","CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations","A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri- Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs","CAMP RWE","Inclusion Criteria:\n\n1. Male or female 18 years of age and older\n2. 2\\. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of \\>4 weeks duration and visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks\n3. Subjects' wound size is minimum of 2 cm2 and maximum of 25cm2\n4. If the subject has more than one eligible wound the largest wound will be selected (the index wound)\n5. Subject is able and willing to follow the protocol requirements\n6. Subject has signed informed consent\n\nExclusion Criteria:\n\n1. Inability to adhere to the study protocol or study visit schedule\n2. Pregnancy\n3. Child-bearing potential without appropriate contraception\n4. Lactation\n5. Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.\n6. Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)\n7. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety\n8. Known contraindications to the use of amniotic tissue grafts\n9. The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics",{"count":436,"type":22},165,[58],"CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs",[30,94,440],"Wound; Foot",[442,443,28,444],"DCF","VLU","Venus Leg Ulcer","2025-10-21",{"date":447,"type":39},"2025-10-22",{"date":449,"type":39},"2025-10-01",{"date":451,"type":22},"2026-07-20",{"name":453,"class":191},"Capsicure, LLC",7,{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":477},"100609047","phase-4-effect-of-amnio-maxx-on-the-healing-rate-of-chronic-diabetic-foot-ulcers-100609047","NCT07209475","Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.","A Randomized Controlled Multicenter Trial, Examining the Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.","Inclusion Criteria:\n\nPotential subjects are required to meet all the following criteria for enrollment into the study and subsequent randomization.\n\n1. The potential subject is 18 years of age or older. At least 50% of the enrolled population must be \\> 65 years of age.\n2. The potential subject has a history of Type I or Type II Diabetes Mellitus requiring treatment by a physician with either oral medications and\u002For insulin replacement therapy.\n3. Potential subjects have an ulcer characterized by the following:\n\n   1. Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided it is at or below the aspect of the medial malleolus. \\[NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study. Index ulcer must be more than 5 cm distant apart.\\]\n   2. A diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.\n4. Objectively, less than 20% healing in the two-week screening period prior to randomization.\n5. Study ulcer is a minimum of 1.0cm2 and a maximum of 25 cm2 post-debridement at first treatment visit.\n6. Index ulcer and\u002For index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1\n7. The subject is able and willing to follow the protocol requirements.\n8. Subject has signed informed consent. Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg; an ABI between 0.7 and ≤ 1.3, or TBI of \\>6 within 3 months of the first Screening Visit.\n\n10\\. Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile). Females of childbearing potential must be willing to use acceptable methods of contraception (birth control methods, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.\n\n11\\. The index ulcer has been offloaded with protocol defined offloading device throughout the study run-in period for at least 14 days prior to randomization (Run-in period defined as Screening through TV1\u002FRandomization).\n\n12\\. The index ulcer has a clean base and is free of necrotic debris at time of placement of treatment product.\n\nExclusion Criteria:\n\n1. The Subject has a known life expectancy of \\\u003C 1 year.\n2. Index ulcer has been present for \\>1 year.\n3. Patient does not have adequate 2-week historical data demonstrating \\\u003C 20% area reduction.\n4. Subject is unable to comply with offloading device.\n5. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.\n6. Subject has ulcers that are completely necrotic or fibrotic tissue\n7. Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.\n8. Subject currently being treated for an active malignant disease\n9. or subjects with history of malignancy within the ulcer.\n10. The Subject has other concurrent conditions that in the opinion of the Principal Investigator may compromise subject safety.\n11. Known contraindications to amniotic tissue membranes or known allergies to any of the Amnio-Maxx components.\n12. Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.\n13. Index ulcer has reduced in area by 20% or more after 2 weeks of standard of care from the first screening visit (S1) to the TV1\u002Frandomization visit.\n14. Subject is pregnant or breastfeeding.\n15. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids\n16. \\>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 30 days prior to randomization visit or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.\n17. Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days preceding the first treatment visit.\n\n    \\-",{"count":463,"type":22},248,[25],"This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.",[30,467],"Amnio-Maxx","2025-10-02",{"date":470,"type":39},"2025-10-07",{"date":472,"type":39},"2025-08-14",{"date":474,"type":22},"2026-08-14",{"name":476,"class":46},"Royal Biologics",8,{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":488,"briefSummary":489,"conditions":490,"keywords":492,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":4},"100608846","chemfoot-debrichem-in-chronic-diabetic-foot-wounds-100608846","NCT07206862","CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds","Clinical Evaluation of the Addition of DEBRICHEM® to the Routine Management of Chronic Diabetic Foot Wounds: an Open-label Randomized Controlled Trial (CHEMfoot Study)","CHEMfoot","Inclusion Criteria:\n\n* Adults ≥18 years.\n* Diabetic foot ulcer (toe, dorsal, plantar, or lateral foot) persisting ≥4 weeks without improvement.\n* Requires debridement.\n* Wound size 0.5-10 cm².\n* Texas classification 0-IIC (controlled neuro-ischemic ulcers, localized infection only).\n* HbA1c ≤10% in last 3 months. Peripheral arterial disease controlled, no critical limb ischemia (toe pressure \\>50 mmHg OR ankle pressure \\>70 mmHg OR TcPO2 \\>30 mmHg).\n\nExclusion Criteria:\n\n* Allergy to DEBRICHEM® components.\n* Active malignancy, osteomyelitis, fasciitis, exposed cartilage.\n* Revascularization \\\u003C4 weeks prior.\n* Systemic infection.\n* Pregnant or breastfeeding women.\n* Vulnerable populations under legal protection.\n* Participation in another clinical trial.",{"count":487,"type":22},242,[58],"This multicenter, randomized controlled trial will evaluate the effectiveness and safety of DEBRICHEM®, a topical desiccant gel, when added to standard care for chronic diabetic foot wounds. Chronic diabetic foot ulcers affect up to 25% of people with diabetes and are associated with high risks of infection, hospitalization, amputation, and mortality. Biofilm formation plays a key role in wound chronicity and delayed healing. DEBRICHEM® is designed to chemically debride wounds by removing biofilm in a single topical application, potentially accelerating the healing process.\n\nA total of 242 adult patients with chronic diabetic foot ulcers (≥4 weeks, 0.5-10 cm²) will be randomized to receive either conventional wound care plus a single application of DEBRICHEM® or conventional wound care alone. The primary endpoint is the proportion of patients achieving complete wound healing at 20 weeks. Secondary outcomes include wound size reduction, infection rates, pain, quality of life, sleep, healthcare resource use, and safety.",[30,242,491],"Diabetic Foot Wounds",[493,494,495,496,29,67],"chemical debridement","DEBRICHEM","topical desiccating agent","TDA",{"date":498,"type":39},"2025-10-03",{"date":500,"type":22},"2025-10",{"date":502,"type":22},"2027-02",{"name":504,"class":46},"DEBx Medical B.V.",{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":516,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":527,"locationsCount":529},"100603950","care-d-foot-nav-pilot-100603950","NCT07143175","CARE-D-FOOT-Nav Pilot","Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav), a Single-arm Pilot Study","Inclusion Criteria:\n\n* Adults (≥18 years old) with diabetes admitted to the hospital for any reason who undergo a DFU-related amputation of 2 or more digits (including minor and major amputations)\n* English-speaking patients (available patient navigators are English-speaking).\n\nExclusion Criteria:\n\n* Patients who are unable to understand the nature and scope of the study,\n* Enrolled in another clinical trial,\n* Planned discharge to an acute or long-term care facility,\n* Planning to receive outpatient DFU care outside of Grady.",{"count":7,"type":22},[58],"This pilot study aims to examine the implementation of a patient navigator intervention called Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav).\n\nUp to one-third of the 37 million people living with diabetes in the United States will experience a diabetic foot ulcer in their lifetime, and non-healing diabetic foot ulcers are the reason for almost all 100,000 diabetes-related amputations that occur annually in this country. Multidisciplinary diabetic foot care improves ulcer healing; however, people face challenges in navigating the healthcare system to access high-quality, multidisciplinary care, and amputations are on the rise.\n\nParticipants enrolled in Care-D-Foot-Nav will be assigned to a diabetes educator and\u002For registered dietitian, and\u002For medical assistant who will serve as a dedicated DFU patient navigator. The navigators will conduct 30-60-minute encounters by phone or in person at least once a week during the 20-week program. The navigator will provide additional resources depending on the unique needs and circumstances of the participant. In addition, participants may receive transportation assistance and wound care supplies if needed.\n\nThis pilot study aims to evaluate the program's fidelity and acceptability. The findings of this study may provide a new and cost-effective approach to managing this devastating disease.",[30],[517,518,519,520],"Assistance for Effective Diabetic Foot Navigation","Navigators","Wound care","Wound healing","2025-08-19",{"date":523,"type":39},"2025-08-27",{"date":525,"type":39},"2025-08-05",{"date":43,"type":22},{"name":528,"class":79},"Emory University",4,{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":357,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":540,"conditions":541,"keywords":542,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":4},"100600395","phase-1-controlled-trial-to-evaluate-the-safety-and-efficacy-of-cywc628-human-dermal-fibroblast-spheroids-for-the-treatment-of-refractory-diabetic-foot-ulcers-compared-with-standard-of-care-100600395","NCT07096934","Controlled Trial to Evaluate the Safety and Efficacy of CYWC628 (Human Dermal Fibroblast Spheroids) for the Treatment of Refractory Diabetic Foot Ulcers Compared With Standard of Care","A Prospective, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of CYWC628 (Human Dermal Fibroblast Spheroids) for the Treatment of Refractory Diabetic Foot Ulcers Compared With Standard of Care","Inclusion Criteria:\n\n1. Males or females aged 18 to 80 years inclusive at time of informed consent.\n2. Diagnosed\u002Fconfirmed Type 1 or 2 diabetes mellitus.\n3. Presence of diabetic foot ulcer (DFU) at or below the level of the malleolus that is confined to one anatomical site and without exposure of bone and\u002For joint capsule.\n4. DFU Wagner Grade 1 or 2.\n5. DFU present for 12 to 52 weeks at time of Screening.\n6. DFU cross-sectional area of 50 to 1000 mm2 at Screening and Day 1.\n7. Resting ankle brachial index (ABI) ≥0.6 and ≤1.2, or toe pressure \\>30 mmHg.\n8. HbA1c \\\u003C9%.\n9. Non-infected DFU (i.e., Infectious Diseases Society of America \\[IDSA\\] International Working Group on the Diabetic Foot \\[IWGDF\\] Classification 1\u002FUninfected) OR, at the discretion of the Investigator, DFU infection of IWGDF\u002FIDSA Classification 2\u002FMild, at least within 2 weeks before and on Day 1.\n\n   At the discretion of the Investigator, if the DFU infection is IWGDF\u002FIDSA Classification 3\u002F Moderate at Screening, the Screening period may be extended to allow time to reduce the infection to IWGDF\u002FIDSA Classification 2\u002F Mild or 1\u002F no infection at least 2 weeks before randomization on Day 1. Otherwise, DFU infection of IWGDF\u002FIDSA Classification ≥3 and\u002For any infection involving bone (osteomyelitis), is exclusionary.\n\n   If there is evidence of infection during the Screening period (i.e., only IWGDF\u002FIDSA Classification 2\u002F Moderate or 3\u002F Severe), the following will be performed:\n   * A skin pathogen test;\n   * Treatment with systemic or topical antibiotic or antifungal as deemed required by the Investigator. Systemic treatment must have ceased at least 5 days before Day 1. Ongoing topical antibiotic or antifungal treatment after randomization is permitted;\n   * Continue treatment of IWGDF\u002FIDSA Classification 3\u002F Moderate infection as required until reduced to IWGDF\u002FIDSA Classification 2\u002F Mild or 1\u002F no infection by at least 2 weeks before Day 1\n   * Sharp debridement of any further necrotic tissue, slough, or biofilm as needed.\n10. If participant of child bearing potential, must have a negative serum pregnancy test at screening and negative urine pregnancy test pre-first treatment on Day 1, and must agree to remain sexually abstinent, or use medically effective contraception (refer to Appendix 11.1), or have a partner who is sterile or same-sex, from Screening until at least 60 days after the last dose of study treatment. Males must not be planning to father children or donate sperm for the duration of the study and for at least 90 days after the last dose of study product.\n11. Understands and is able and willing to participate and comply with study requirements including attending study visits and follow-up.\n\nExclusion Criteria:\n\n1. The DFU had been previously treated, or is being treated, with growth factors, stem cells, or any equivalent preparation within 8 weeks before Screening.\n2. Enrolment in another interventional clinical foot ulcer healing trial within 4 weeks before Screening, or participation in any other interventional research study within 8 weeks before screening.\n3. Additional wound(s) within 3 cm of the study target wound.\n4. History of conditions that may impair wound healing in the opinion of the Investigator, for example, autoimmune disorders, renal failure patients on dialysis, or medications that impair the healing process. .\n5. DFU with exposure of bone and\u002For joint capsule.\n6. Active osteomyelitis, cellulitis, soft tissue infection, or Charcot's arthropathy present on the affected foot or limb containing the DFU, or DFU infection IWGDF\u002FIDSA Classification 4\u002F Severe, or DFU infection IWGDF\u002FIDSA Classification 3\u002F Moderate at Screening that cannot be reduced to Classification 2\u002F Mild or Classification 1\u002F No infection with treatment.\n7. Active healing and reduction of wound area ≥30% during the two-week period before Day 1.\n8. Known allergy to topical dressings, any of the study treatment components, and\u002For to gentamicin or other aminoglycosides.\n9. Use of systemic antibiotics or antifungals for treatment of or prophylaxis for DFU infection within 5 days before Day 1, and\u002For if such use is considered by the Investigator likely to be required during the study treatment period. Systemic antibiotic or antifungal use for other indications is not exclusionary.\n10. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer considered treated and cured) within 5 years of screening, regardless of whether there is no evidence of local recurrence or metastasis. Basal cell carcinomas of the skin are also exclusionary if diagnosed within 6 months before screening. If there is suspicion of skin cancer, a biopsy may be performed during screening for confirmation.\n11. Pregnant or breastfeeding, or a male participant planning to father children or donate sperm during the study and for 90 days after last dose of study treatment.\n12. Current smoker of tobacco products and\u002For active user of nicotine replacement products including but not limited to nicotine gum, patches, or vaping.\n13. Current alcohol misuse as determined by the Investigator, and\u002For positive alcohol breath test at screening or pre-first treatment (no re-test permitted).\n14. Substance use disorder of any severity as determined by the Investigator, including any use of illicit drugs or other addiction which might interfere with the ability to comply with study procedures in the opinion of the Investigator; positive urine drug test at screening or pre-first treatment (tricyclic antidepressants, opioids, cannabidiols \\[CBDs\\] and benzodiazepines are not exclusionary if prescribed by a physician and consistent with medical history). One re-test permitted for urine drug test where justified in the opinion of the Investigator (e.g., false positive suspected).\n15. Any other condition or situation that, in the opinion of the Investigator, would compromise the participant's ability to comply with study requirements.\n16. Known history of poor compliance with medical treatments.",{"count":385,"type":22},[124,539],"PHASE2","This is a prospective, multicentre, randomized clinical trial evaluating the safety, tolerability, and efficacy of up to 12 weeks treatment with SoC + low- or high-dose CYWC628 in treating DFU, compared to SoC only.",[30],[29,543,544,545,546,547,548],"Diabetic ulcers","diabetic wounds","diabetic foot ulcers","chronic wounds","chronic ulcers","non-healing wounds","2025-07-29",{"date":551,"type":39},"2025-07-31",{"date":553,"type":22},"2025-09",{"date":555,"type":22},"2027-03",{"name":557,"class":79},"FibroBiologics",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":568,"briefSummary":569,"conditions":570,"keywords":572,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":47},"100593264","implementation-of-a-diabetic-foot-prevention-strategy-in-primary-care-implanta-study-100593264","NCT07004179","Implementation of a Diabetic Foot Prevention Strategy in Primary Care (iMplanta Study)","Implementation of a Diabetic Foot Prevention Strategy in Primary Care: Study Protocol for Two-arm Cluster Randomised Controlled Trial (iMplanta Study)","iMplanta","Inclusion Criteria:\n\n* Diagnosis of type 1 or type 2 diabetes mellitus.\n* Aged 18 years or older.\n* Attending nursing consultations at participating primary care centers during the study period.\n\nExclusion Criteria:\n\n* Patients with gestational diabetes.\n* Patients with diabetic foot ulcers prior to the start of the study.\n* Patients with lower limb amputations prior to the start of the study.",{"count":567,"type":22},1520,[58],"The goal of this two-arm cluster randomised controlled trial (RCT) is to evaluate the effectiveness of a new implementation strategy based on the ImM model for the Protocol of assistance to the person with diabetic foot (PAPDF) of the Balearic Islands Health Service in reducing complications of diabetic foot, compared to the current implementation strategy, in the primary care centers of Majorca. As secondary objectives we aim 1. To determine the reach of the implementation strategy in the GAPM primary care centers, 2.To compare the effectiveness of the PAPDF versus usual care in preventing diabetic foot complications, 3. To identify the number of healthcare professionals adhering to the implementation strategy and 4. To assess the sustainability of the implementation strategy over time.",[571,30],"Diabetic Foot Disease",[573,574,575,576],"Diabetic foot","Implementation Sciencie","Prevention","Primary Care","2025-06-25",{"date":579,"type":39},"2025-06-29",{"date":581,"type":22},"2025-09-01",{"date":583,"type":22},"2026-12-22",{"name":585,"class":79},"University of the Balearic Islands",{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":23,"phases":595,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":604,"locationsCount":47},"100596637","phase-1-safety-and-preliminary-efficacy-of-trophipatch-an-adipose-derived-stromal-cell-patch-for-chronic-leg-ulcers-100596637","NCT07048054","Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcers","Allogenic Adipose-derived Stromal Cell Patch (i.e TrophiPatch, Provided by HekeTiss®) for Chronic Leg Ulcers Resistant to Standard Treatment: Safety and Preliminary Efficacy, a One-arm Monocentric Phase I-ll Trial","RESCUE-PATCH","Inclusion Criteria\n\n* Age 18 years or older.\n* Patients with more than one eligible ulcer will have one - usually the largest or more clinically significant - selected at screening as the index ulcer.\n* Participants will have the capacity to understand study procedures, and will be able to providewritten informed consent.\n\n(for VLU only)\n\n* Diagnosed with at least one venous leg ulcer.\n* Ulcers duration for 6 weeks to 3 years at the time of screening.\n* Hard-to-healed ulcers with cross-sectional area that have decreased by less than 40% during a four-week run-in period.\n* Reference ulcer surface from 5 to 25 cm2.\n* At the time of inclusion, the ulcer will be clinically non-infected (TILI score ≥ 5).\n* Absence of significant arterial insufficiency assessed at clinical examination (intermittent claudication or resting pain, necrotic or distal wound on the foot) and systolic homolateral ankle-brachial index (ABI) greater than 0.75 and inferior to 1.40 or biphasic or triphasic Doppler signals in the dorsalis or posterior tibial arteries of the affected limb.\n\n(for DFU only)\n\n* Patient with type 1 or type 2 diabetes.\n* Diagnosed with at least one diabetic foot ulcer on a foot or both feet below the level of the malleoli, excluding ulcers confined to the interdigital cleft.\n* Ulcers duration for 4 weeks to 3 years at the time of screening.\n* Eligible ulcers will be hard-to-heal, meaning that the cross-sectional area will decrease by less than 50% during a four-week run-in period.\n* Reference ulcer surface from 1 to 25 cm2.\n* At the inclusion, the ulcer will be clinically non-infected (according to IDSA criteria).\n* HbA1C \\\u003C 12% at screening.\n* Absence of significant arterial insufficiency assessed by systolic homolateral ankle-brachial index (ABI) greater than 0.75 and inferior to 1.40 or biphasic or triphasic Doppler signals in the dorsalis or posterior tibial arteries of the affected limb.\n\nExclusion Criteria\n\n* Subject has a history of:\n\n  * endstage renal disease\n  * uncontrolled cardiac failure\n  * severe malnutrition\n  * severe liver disease\n  * aplastic anemia\n  * malignant disease (active or recent (\\\u003C5 years))diabetes avec HbA1C \\> 12%\n  * rheumatoid arthritis\n  * sickle cell disease\n  * other connective tissue disorder\n  * irradiation to the affected extremity\n* Serum creatinine concentration greater than 180 umol\u002FL and\u002For receipt of renal dialysis or an estimated glomerular filtration rate (based on cystatin C or serum creatinine) of less than 20 mL\u002Fmin per 1·73 m²\n* Drug or alcohol abuse.\n* Limited physical capacity or total immobility.\n* Known pregnancy or nursing at the time of screening visit\n* Subject is currently receiving (i.e within 30 days prior to inclusion) or scheduled to receive a medication or treatment that, in the opinion of the investigator, will interfere with or affect the rate of wound healing.\n* Index ulcers probing to tendon, muscle, capsule and bone.\n* Local or systemic signs of ongoing infection.\n* Hypersensitivity to silicone or porcine gelatin.\n* Previous treatment with growth factors, stem cells, or an equivalent preparation within the 8 weeks before the baseline visit.\n* Involvement in another interventional clinical trial within the 4 weeks before the baseline visit.\n* Known or suspected absence of capacity to understand the study procedures or provide written informed consent (decided by the investigator).\n* Cross-sectional area of the index ulcer had increased by at least 20%.\n\n(for VLU only)\n\n* History of poor compliance with compression therapy.\n* Presence of peripheral neuropathy of the lower limbs.\n\n(for DFU only)\n\n• History of poor compliance with offloading therapy.",{"count":405,"type":22},[124,539],"This study aims to evaluate the safety and effectiveness of an experimental biological dressing called TrophiPatch, applied to adults with chronic leg ulcers of diabetic or vascular orign. TrophiPatch contains stromal cells derived from a donor's fat tissue, which are purified and processed in a certified laboratory. These cells have shown wound-healing, anti-inflammatory and pro-angiogenic properties in preclinical studies.\n\nAll 18 participants will receive a single application of TrophiPatch on their wound. The total study duration is up to 24 weeks, with 23 scheduled visits for follow-up and monitoring.",[30,265],"2025-06-24",{"date":600,"type":39},"2025-07-02",{"date":602,"type":22},"2025-07",{"date":276,"type":22},{"name":605,"class":79},"Nicolò Brembilla",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":238,"phases":4,"briefSummary":615,"conditions":616,"keywords":617,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":623,"leadSponsor":624,"locationsCount":47},"100593977","study-to-assess-remote-imaging-system-to-monitor-diabetic-foot-ulcers-100593977","NCT07013448","Study to Assess Remote Imaging System to Monitor Diabetic Foot Ulcers","Pilot Study of a Novel Non-invasive Multimodal Imaging System in the Monitoring of Diabetic Foot Ulcer Progression","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Diagnosed with a diabetic foot ulcer at the time of recruitment\n* Receiving routine care at the participating NHS clinic\n* Able to provide informed consent\n* Able to sit and engage with the TASHA scanning device\n* Willing to attempt a supervised self-scan of the affected foot\n\nExclusion Criteria:\n\n* Presence of non-diabetic foot ulcers\n* Severe cognitive or physical impairments that prevent scanning or understanding instructions\n* Active infection or medical instability requiring urgent intervention\n* Participation in another interventional study that may interfere with this assessment\n* Inability to communicate in English (unless appropriate translation or support is available)",{"count":614,"type":22},40,"The goal of this observational pilot study is to evaluate whether a new remote monitoring platform (TASHA) can support accurate and reliable assessment of diabetic foot ulcers in adult patients receiving care in a UK NHS clinic. The main questions it aims to answer are:\n\nCan the TASHA platform provide ulcer assessment data (e.g., size, depth, visible infection) that aligns with in-clinic evaluations by healthcare professionals? Can patients accurately perform self-scanning of their ulcers using the platform under clinical supervision? What is the variation (inc. root mean square error) between clinician-led and patient-led scans?\n\nParticipants will:\n\n* Attend a standard in-clinic ulcer assessment as part of their usual care Undergo an additional 3D foot scan using the TASHA platform during their clinic visit.\n* Be guided to perform a self-scan using the same platform, with clinical staff present.\n* Have their scan data reviewed remotely by a clinician to compare with in-clinic assessments.\n* This feasibility study will inform the design of future larger-scale trials and contribute to regulatory development of the TASHA platform as a digital medical device.",[28,30],[29,618],"Monitoring","2025-06-02",{"date":621,"type":39},"2025-06-10",{"date":553,"type":22},{"date":402,"type":22},{"name":625,"class":46},"Medical Intelligence Group",{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":632,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":23,"phases":636,"briefSummary":637,"conditions":638,"keywords":639,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":4},"100590179","evaluation-of-cold-plasma-in-chronic-wound-healing-100590179","NCT06964048","Evaluation of Cold Plasma in Chronic Wound Healing","Evaluation of Cold Plasma in Wound Healing: A Randomized Controlled Pilot Study on Chronic Venous Leg Ulcers and Diabetic Foot Ulcers.","PLASANAGENESIS","Inclusion Criteria:\n\n* Adult patient, age ≥ 18 years,\n* Patients affiliated with a social security system or benefiting from such a system,\n* Patients able and willing to provide written informed consent,\n* Patients able and willing to attend regular follow-up visits during up to 20 weeks, and comply with study procedures,\n* Patients whose home healthcare professional is willing to follow the clinical investigation protocol,\n* Patient with gas conformed stockage area (ventilated or at least 7m²)\n* Patients without infection, or with a local controlled infection,\n* Patients with VLU:\n\n  * Patients with wound anteriority between 1 to 12 months\n  * Patients with VLU or mixed ulcer of predominantly venous origin (measured ankle brachial index (ABI) such as 1.3 ≥ ABI ≥ 0.8)\n  * Patients with VLU between 4 to 30 cm² in surface area,\n  * Patients with only one VLU,\n  * Patients who have not shown wound healing improvement after wearing compression system for at least two weeks\n* Patients with DFU:\n\n  * Patients with wound duration between 1 to 12 months\n  * Patients with DFU and with measured ABI ≥ 0.8 or Toe Brachial Index (TBI) ≥ 0.7\n  * Patients with DFU between 1 to 30 cm² in surface area,\n  * Patients with only one DFU, not between toes,\n  * Patients who have not shown wound healing improvement after wearing an offloading system for at least two weeks,\n* Patient with PU:\n\n  * Patient with wound duration between 1 to 12 months\n  * Patient with PU stage 2 or 3 NPUAP grade,\n  * Patient with PU and with ABPI ≥ 0.8 and ≤ 1.3 and\u002For Toe Brachial Index (TBI) ≥ 0.7 if PU on the foot\n  * Patient with PU between 4 to 30 cm² in surface area,\n  * Patient with only one PU\n  * Patient able and willing to wear off loading system or to be install on pressure relieving system et changing position regularly,\n\nExclusion Criteria:\n\n* Patients with any other wound treatments other than SOC, Patients who has undergone surgery or surgical revascularization (vascular reconstruction or angioplasty) since less than three months, except for VLU patients who have undergone local graft surgery included in VLU SOC.\n* Patients with an active Charcot's neuro-arthropathy as determined by clinical and\u002For radiographic examination,\n* Patients with critical limb ischemia or severe PAD (ankle pressure \\\u003C 50 mmHg or Toe pressure \\\u003C 30 mmHg).\n* Patients with conditions that may affect wound healing, such as rheumatoid arthritis, scleroderma, or tumor wounds.\n* Patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant,\n* Patients with non-controlled systemic infection by a suitable antibiotic,\n* Patients with suspicion of severe malnutrition,\n* Pregnancy or breastfeeding woman, or susceptible to be pregnant,\n* Patients with known allergy or hypersensitivity to components of the cold plasma device or standard wound care products,\n* Patients included in another study,\n* Patients under guardianship or protection of vulnerable adult.\n* Patients with implantable electro-medical devices.\n* Patients with a history of hypersensitivity or known allergy to medical argon or any component of the device.\n* Infected wounds requiring urgent medical or surgical treatment before the application of any device.",{"count":635,"type":22},66,[58],"The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds. The main questions is the following: Does the application of cold atmospheric plasma accelerate wound healing compared to standard wound care alone?\n\nResearchers will compare standard of care plus plasma treatment with standard of care alone to see if the plasma-treated group shows faster wound healing.\n\nParticipants will:\n\n* Receive either standard wound care alone or standard wound care combined with cold atmospheric plasma treatment, depending on randomization.\n* Attend scheduled hospital visits for wound care, treatment administration, and clinical assessments, including wound photography and quality of life questionnaires.\n* Be followed up at home by nurses for wound care, treatment administration and clinical assessment too.\n* Complete a wound-related quality of life questionnaire at baseline, at week 6, and at the end of the study.",[101,265,30,92],[640,94,443,28,29,641,642,643,644,645,646,647,648],"Chronic wounds","Pressure Ulcer","PU","Cold Atmospheric Plasma","CAP","Plasma","Cold Plasma","Healing","Wound Closure","2025-04-30",{"date":651,"type":39},"2025-05-09",{"date":653,"type":22},"2025-06",{"date":655,"type":22},"2026-05",{"name":657,"class":46},"Plasana Medical",{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":23,"phases":667,"briefSummary":668,"conditions":669,"keywords":671,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":699},"100568453","rising-tide---amniotic-tissues-treatments-for-chronic-diabetic-foot-ulcers-100568453","NCT06681428","Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers","A Multi-Center, Randomized Controlled Clinical Investigation Evaluating an Amnion\u002FChorion\u002FAmnion Allograft, Amnion\u002FChorion Allograft, And\u002For an Amnion\u002FAmnion Allograft Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers","Inclusion Criteria:\n\nPotential subjects are required to meet all of the following criteria for enrollment into the study.\n\n1. At least 18 years old, inclusive.\n2. Presence of a DFU, Wagner Grade 1, extending through the dermis provided it is below the medial aspect of the malleolus.\n3. The index ulcer (ulcer to be evaluated in the study) will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.\n4. Index ulcer has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.\n5. Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.\n6. Within 3 months of SV1, adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \\> 0.6 is acceptable.\n7. The target ulcer has been offloaded for at least 14 days, prior to TV1.\n8. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.\n9. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.\n10. Subjects must have read and signed the IRB approved ICF before screening procedures are performed.\n\nExclusion Criteria:\n\nPotential subjects meeting any of the following criteria will be excluded from enrollment and subsequent treatment.\n\n1. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes\n2. Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer\n3. Index ulcer is infected\n4. Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study\n5. Subjects on any investigational drug(s), Investigational products, or therapeutic device(s) within 30 days preceding SV1\n6. History of radiation at the ulcer site (regardless of time since last radiation treatment)\n7. Index ulcer has been previously treated or will need to be treated with any prohibited therapies\n8. Subjects with a previous diagnosis of HIV or Hepatitis C\n9. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment\n10. Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision)\n11. Subject is pregnant or breast-feeding\n12. Presence of diabetes with poor metabolic control as documented with an HbA1c \\>12.0 within last 90 days\n13. Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg\u002FdL within 6 months of enrollment\n14. Presence of acute Charcot Neuroarthropathy to the affected limb\n15. Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1\u002FRandomization visit",{"count":666,"type":22},240,[58],"The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion\u002FChorion\u002FAmnion allograft , Amnion\u002FChorion allograft, and\u002For Amnion\u002FAmnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.",[30,670],"Chronic Foot Ulcers",[672,673,674,675,676,61,677,678,679,680,33,215,681,682,683,684,685,686,687,688,689],"Amnion","Chorion","Amnion Amnion Graft","Amnion Chorion Amnion Grafts","Amnion Chorion Graft","Glucose Metabolism Disorders","Metabolic Diseases","Endocrine System Diseases","Pathologic Processes","Chronic Ulcer","Chronic Foot Ulcer","Diabetic Angiopathies","Diabetes Type 2","Diabetes Type II","Leg Ulcer","Placental-Based Allografts","Human Placental-Based Skin Grafts","Skin Wound Covering","2025-02-06",{"date":692,"type":39},"2025-02-10",{"date":694,"type":39},"2024-11-14",{"date":696,"type":22},"2026-11-18",{"name":698,"class":46},"Tides Medical",9]