[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-foot\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-foot":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,41,0,25,[9,49,86,114,142,171,199,227,257,286,307,330,363,386,414,435,462,525,550,574,600,625,643,666,697],{"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":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100512300","wiredup-wearable-insoles-for-recurrent-diabetic-ulcer-prevention-100512300",false,"NCT05950659","WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention","Prevention of Foot Ulcer Recurrence in Individuals Who Are at High-risk for Diabetic Foot Complications Using the Orpyx Sensory Insole System: a Multisite, Randomized, Controlled Trial","WIREDUP","Inclusion Criteria:\n\n* Diagnosed Type 1 or 2 diabetes\n* Clinically diagnosed neuropathy via Neuropathy Monofilament Test (Appendix A)\n* Qualification as a \"high-risk participant,\" meaning a recent history (\\\u003C12 months) of a healed diabetic neuropathic ulceration on the weight-bearing surface of one or both feet (this includes the plantar distal toe surface)\n* Complete healing of any previous foot ulcers, as defined by complete re-epithelialization of that ulcer which is confirmed by two medical exams that occur at least two weeks apart (screening visit and baseline study visit)\n* Ability to walk independently (without use of wheelchair) for 30 steps. Use of a walker or cane is acceptable as long as the participant can walk for at least 30 steps.\n* Aged \\>18 years\n* ABI \\> 0.6 or TBI \\> 0.4 or palpable pulses or evidence of healing in the last 2 months. If ABI \\\u003C 0.4, the patient's vascular lab studies (ABI, TBI, pulse volume recordings) will be reviewed by the study PI and a co-I vascular surgeon at USC.\n* Subject is willing and able to maintain the required offloading (as applicable for the location of the healed ulcer)\n* Subject is willing and able to wear the Orpyx Sensory Insoles during ambulatory activity and at home during waking hours, and for a minimum of 5 hours per day\n* Amputations, if present, are compatible with the use of insoles at physician discretion (e.g. Transmetatarsal Amputation (TMA) are acceptable)\n\nExclusion Criteria:\n\n* Active ulcer or presence of other open chronic wound (on foot or leg), regardless of etiology (e.g., vasculitis, neoplasms, or hematological disorders)\n* Dementia\n* Psychiatric illness or social situations that would limit compliance with the study\n* Significant cardiopulmonary, severe imbalance, or other systemic disease limiting the participant's ability to walk at least 30 steps or to stand for an amount of time equal to or greater than five (5) minutes (self-reported)\n* Current participation in another clinical investigation of a similar medical device designed to offload or prevent diabetic foot ulcer formation; or participation in such a study within 30 days prior to study enrollment, per physician discretion\n* Current enrollment in any other remote patient pedal monitoring (RPPM) program\n* Osteomyelitis or gangrene of the lower extremity\n* Uncorrected plantar Charcot neuroarthropathy\n* Bunion which would predispose ulcer formation (clinician discretion)\n* Extreme equinus\n* At the start of V1, and prior to randomization, the subject no longer meets the entrance criteria (inclusion and exclusion)\n* Above ankle amputation\n* Amputations not compatible with the insole, per physician discretion\n* Foot deformities or amputations that require surgical intervention as the next step in standard of care, and that the study footwear and device would not adequately address (to be adjudicated by an outside review panel).\n* Brannock-measured foot size \\> Men's 14 (Women's 12)\n* Physician discretion","ALL","18 Years",{"count":21,"type":22},400,"ESTIMATED","INTERVENTIONAL",[25],"NA","The primary aim of this study is to demonstrate the impact of the Orpyx® Sensory Insoles (Orpyx Medical Technologies Inc., Calgary AB, Canada) (\"Orpyx\" or \"the Company\") as an adjunct to the standard of care (SOC), as compared to SOC alone, on reducing plantar ulceration incidence in individuals who are at risk for developing diabetic foot complications.\n\nThe secondary aims of this study are to evaluate participant quality of life, participant engagement, and economic impact, including cost-effectiveness and cost-utility. The study will also use the unique data set collected (plantar pressure, temperature, step count, movement and adherence feedback) to identify foot-loading histories that either lead to or prevent the development of ulceration in the diabetic foot.",[28,29,30,31],"Diabetes","Peripheral Neuropathy","Diabetic Foot","Diabetic Foot Ulcer",[33,34,35],"Remote Patient Monitoring","Sensor-based Monitoring","Sensory Insoles","RECRUITING","2026-06-04",{"date":39,"type":40},"2026-06-08","ACTUAL",{"date":42,"type":40},"2026-04-22",{"date":44,"type":22},"2029-04-01",{"name":46,"class":47},"Johns Hopkins University","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100643797","miro3d-wound-matrix-for-treatment-of-diabetic-foot-ulcers-100643797","NCT07632001","Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers","A Randomized Controlled Multicenter Trial, Examining the Effect of Miro3D Wound Matrix on the Rate of Complete Wound Closure of Chronic Diabetic Foot Ulcers","FOCUS 3D","Inclusion Criteria\n\n1. Subjects 18 years of age or older.\n2. Subject history of Type I or Type II Diabetes Mellitus requiring treatment with oral medications and\u002For insulin replacement therapy.\n3. 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 25% wound area reduction 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.\n\n   Subjects with the following ulcer:\n\n   A. Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided 50% of the wound sits below the level of the malleolus. This includes DFUs as a result of open amputation sites and surgical wound dehiscence as long as all other criteria are met. \\[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 2 cm distant apart.\\]\n9. 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; Toe pressures \\>50mmHg; an ABI between 0.7 and ≤ 1.3, or TBI of \\>0.6 within 3 months of the first Screening Visit.\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 pills, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.\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).\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. 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 25% 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 or subjects with history of malignancy within the ulcer.\n9. The Subject has other concurrent conditions that in the opinion of the Principal Investigator may compromise subject safety.\n10. Known contraindications to acellular dermal matrices or known allergies to any of the Miro3D components.\n11. Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.\n12. Index ulcer has reduced in area by ≥25% after 2 weeks of standard of care from the first screening visit (S1) to the TV1\u002Frandomization visit.\n13. Subject is pregnant or breastfeeding.\n14. Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \\>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.\n15. Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) including any other CAMP within the last 30 days preceding the first treatment visit.\n16. Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of screening visit 1.\n17. Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization (TV1).\n18. Index ulcer and\u002For index limb with presence of gangrene or unstable ischemia at screening (SV1).\n19. Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of Screening Visit (SV1).\n20. 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.\n21. 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":58,"type":22},180,[25],"This study is designed to evaluate whether the Miro3D Wound Matrix, when used in addition to standard of care, improves healing outcomes in patients with chronic diabetic foot ulcers.\n\nDiabetic foot ulcers are a common and serious complication of diabetes and may be difficult to heal despite appropriate treatment. Standard of care typically includes regular wound cleaning, debridement (removal of dead tissue), offloading (reducing pressure on the wound), and moisture-balancing dressings. However, some wounds fail to heal with standard treatment alone.\n\nMiro3D Wound Matrix is a three-dimensional, acellular scaffold derived from porcine tissue that is intended to support wound healing. This study will compare outcomes in patients treated with Miro3D plus standard of care versus standard of care alone.\n\nApproximately 180 adult subjects with non-healing diabetic foot ulcers will be enrolled at multiple clinical sites in the United States. After a two-week screening period, eligible participants will be randomly assigned to receive either Miro3D in addition to standard of care or standard of care alone. Subjects will be followed for up to 12 weeks with weekly clinic visits.\n\nThe primary objective of the study is to determine whether treatment with Miro3D increases the rate of complete wound closure and improves reduction in wound size compared to standard of care alone. Safety will also be evaluated by monitoring adverse events throughout the study.",[62,30,63],"Diabetic Foot Ulcers (DFUs)","Chronic Wounds",[65,66,67,68,31,69,70,71,72,73,74,75],"Miro3D","Wound Matrix","Extracellular Matrix","Acellular Dermal Matrix","Chronic Wound Healing","Advanced Wound Care","Randomized Controlled Trial","Wound Closure","Tissue Regeneration","Offloading","Debridement","2026-06-03",{"date":39,"type":40},{"date":79,"type":22},"2026-06",{"date":81,"type":22},"2027-05",{"name":83,"class":84},"Reprise Biomedical, Inc.","INDUSTRY",14,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":48},"100636289","effectiveness-of-a-structured-educational-program-on-pain-intensity-self-efficacy-foot-self-care-behaviors-and-health-related-quality-of-life-among-adults-with-diabetic-foot-100636289","NCT07563751","Effectiveness of a Structured Educational Program on Pain Intensity, Self-Efficacy, Foot Self-Care Behaviors, and Health-Related Quality of Life Among Adults With Diabetic Foot","Effectiveness of a Structured Educational Program on Pain Intensity, Self-Efficacy, Foot Self-Care Behaviors, and Health-Related Quality of Life Among Adults With Diabetic Foot: A Randomized Controlled Trial","DF-EDU-RCT","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Diagnosed with diabetic foot\n* Able to communicate effectively\n* Willing to participate in the educational program\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Patients with severe or unstable medical conditions (e.g., advanced heart failure, renal failure, or active infections) that may interfere with participation\n* Patients with major lower-limb amputation or severe foot deformities preventing participation in the educational program or assessments\n* Patients with cognitive impairments, psychiatric disorders, or communication difficulties affecting understanding or compliance\n* Pregnant or lactating women\n* Patients who refuse to provide informed consent or withdraw at any stage of the study",{"count":21,"type":22},[25],"This randomized controlled trial aims to evaluate the effectiveness of a structured educational program on pain intensity, self-efficacy, foot self-care behaviors, and health-related quality of life among adults with diabetic foot. Diabetic foot complications are a major cause of morbidity, reduced quality of life, and disability among patients with diabetes mellitus. Poor self-care practices and inadequate knowledge contribute significantly to the progression of foot ulcers and related complications.\n\nParticipants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured educational program designed to improve knowledge, self-management skills, and adherence to recommended diabetic foot care practices. The control group will receive routine care provided by the healthcare facility.\n\nThe educational program focuses on key areas including foot hygiene, daily foot inspection, appropriate footwear, glycemic control, and early identification of warning signs of complications. The primary outcomes of the study include changes in pain intensity, self-efficacy, foot self-care behaviors, and health-related quality of life, which will be assessed at baseline and after the intervention period.\n\nThe findings of this study are expected to contribute to improving nursing educational interventions and enhancing self-management outcomes among patients with diabetic foot.",[30],[99,100,101,102,103],"Pain Intensity","Self-Efficacy","Foot Self-Care Behaviors","Quality of Life","Diabetic foot","NOT_YET_RECRUITING","2026-04-30",{"date":107,"type":40},"2026-05-04",{"date":109,"type":22},"2026-05-01",{"date":111,"type":22},"2026-10-01",{"name":113,"class":47},"Jerash Private University",{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":18,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":48},"100612982","early-phase-1-efficacy-of-a-topical-palmitated-formulation-of-capsaicin-capsadyn-in-the-treatment-of-diabetic-neuropathic-foot-pain-100612982","NCT07260656","Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain","A Double-Blind, Randomized, Pilot Study to Investigate the Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain","Inclusion Criteria:\n\n* At least 3 toes per foot\n* Have otherwise intact feet.\n* Absence of any eczema, hyperkeratosis, scleroderma, or other dermatological conditions afflicting the area of Test Article administration that may interfere with absorption, particularly hyperhidrosis.\n* Must agree to apply the Test Article to painful areas of feet as directed by research personnel.\n* Must agree to apply the Test Article to feet as instructed 2x per day.\n* Must wait 60 minutes after each application of Test Article before filling out NRS forms.\n* Unless burning is encountered soon after application, the participant must wait at least 60 minutes before washing feet after application of Test Article.\n* All participants must be willing to use Test Articles blinded.\n\nExclusion Criteria:\n\n* Younger than 25 and older than 75 years of age\n* Any dermatological condition(s) with the potential to disrupt skin integrity or alter sensory function of the feet.\n* Any open wounds, skin ulceration, infection, skin irritation (e.g., poison oak), history of eczema, trauma or burn (including sunburn) affecting the feet within 30 days.\n* Any recent medical history of surgery affecting the feet.\n* Unless part of a stable continuum of substance use prior to start of study, the use of any topical medication products on feet, including holistic formulations, patch or herbal products, cannabinoid products, prescription or over the-counter (OTC) analgesic creams\u002Flotions\u002Fpatches\u002Fgels, nonsteroidal anti-inflammatory drugs, acetaminophen, counterirritants, local anesthetics, or steroids is prohibited.\n* Current substance abuse.\n* History of hypersensitivity or allergy to chili peppers, coconut oil, Shea butter, or sunflower seed oil.\n* Except for interventions for mobility, (e.g., physical therapy, exercise, grounding) no concurrent foot therapy for pain that may interfere with NRS evaluations is permitted (e.g., massage, electrophoresis, red light, etc.).\n* No concurrent enrollment in another clinical trial.","25 Years","75 Years",{"count":124,"type":22},80,[126],"EARLY_PHASE1","The purpose of this research is to assess whether the use of a topical cream with an active ingredient can reduce the amount of foot pain experienced in participants who have been diagnosed with Diabetic Peripheral Neuropathy (DPN) with minimal side effects or discomfort from use.",[129,30,130],"Diabetic Neuropathies, Painful","Diabetic Peripheral Neuropathy",[132],"diabetic foot pain","2026-04-15",{"date":135,"type":40},"2026-04-20",{"date":137,"type":40},"2025-11-26",{"date":139,"type":22},"2027-11",{"name":141,"class":47},"Carilion Clinic",{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":153,"conditions":154,"keywords":157,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":170},"100537402","peripheral-extreme-revascularization-in-no-option-patiens-with-chronic-limb-threatening-ischemia-100537402","NCT06277362","Peripheral Extreme Revascularization in \"No-option\" Patiens With Chronic Limb Threatening Ischemia","\"Arterial-Venous Reversal Flow in \"No-option\" Chronic Limb-threating Ischemia (CLTI) Patients\"","PiPER","Inclusion Criteria:\n\n* Age ≥18 years\n* Patient has signed an approved informed consent form\n* All patients, with non-revascularizable critical lower limb ischemia defined on the basis of 2 previous unsuccessful Percutaneous Transluminal Angioplasty (PTA) attempts or on severe Medial Artery Calcification (MAC)\u002FSmall Artery Disease (SAD) stage.\n* Patient with Critical Limb Ischaemia, Rutherford category, 5 (minor tissue loss) or 6 (major tissue loss) with active trophic lesions\n* Ejection Fraction \\> 30%\n\nExclusion Criteria:\n\n* Subject no able to perform the follow up or other factors making clinical follow-up difficult\n* Patients with critical ischaemia of the lower limbs revascularizable by bypass or angioplasty, critical ischaemia characterised by rest pain (Rutherford class ≤ 4)\n* Ejection Fraction \\\u003C 30%",{"count":151,"type":22},50,"OBSERVATIONAL","The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with \"no-option\" CLTI.",[155,156,30],"Peripheral Arterial Disease","Critical Limb-Threatening Ischemia",[158,159,160],"PAD","DVA","CLTI","2026-03-23",{"date":163,"type":40},"2026-03-24",{"date":165,"type":40},"2020-01-31",{"date":167,"type":22},"2028-12",{"name":169,"class":47},"EndoCore Lab s.r.l.",9,{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":198},"100260079","phase-1-standard-treatment-associated-with-phage-therapy-versus-placebo-for-diabetic-foot-ulcers-infected-by-s-aureus-100260079","NCT02664740","Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus","Comparison of the Efficacy of Standard Treatment Associated With Phage Therapy Versus Standard Treatment Plus Placebo for Diabetic Foot Ulcers Monoinfected by Staphylococcus Aureus: a Randomized, Multi-centre, Controlled, 2-parallel-group, Double-blind, Superiority Trial","PhagoPied","Participant pre-inclusion criteria:\n\n* The patient must have given his\u002Fher informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is at least 18 years old\n* The patient has type 1 or type 2 diabetes\n* The patient is hospitalized\u002Fconsulting in a participating centre\n* The patient has a wound below the ankle that has be evolving for \\>2 weeks\n* The patient has a neuropathic foot wound, classified S (0 or 1), I (0 or 1), N (1), B (1), A (0 or1) and D (1) according to the SINBAD classification,\n\n  * without ischaemia or with non-critical ischaemia defined by: ankle arterial pressure \\> 50 mm Hg or toe systolic arterial pressure \\> 30 mm Hg or TcpO2 \\> 30 mm Hg )\n  * with a surface area ≥ 0,5 cm2\n  * With IWGDF\u002FIDSA grade 2 or 3 infection without osteomyelitis (normal radiography\\*)\n* Females of childbearing potential or Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices) for 1 month after the last study drug administration\n* Negative pregnancy test must be obtained before starting any experimental drug\n* Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)\n\nParticipant final inclusion criteria:\n\n* The patient has a neuropathic foot wound:\n\n  * Classified S (0 or 1), I (0 or 1), N (1), B (1), A (0 or1) and D (1) according to the SINBAD classification,\n* without ischaemia or with non-critical ischaemia defined by: ankle arterial pressure \\> 50 mm Hg or toe systolic arterial pressure \\> 30 mm Hg or TcpO2 \\> 30 mm Hg )\n* with a surface area ≥ 0,5 cm2\n\n  * With IWGDF\u002FIDSA grade 2 or 3 infection without osteomyelitis\n* The patient's wound is monoinfected by methicillin-resistant or susceptible S. aureus (MSSA or MRSA ), or infected by MSSA or MRSA and other bacteria (a total of 3 bacteria when accounting for MSSA or MRSA)\n* The Phagogram of the patient demonstrated that the strains are susceptible to at least one phage(PP1493 and\u002For PP1815).\n\nParticipant pre-exclusion criteria:\n\n* The patient is participating in, or has participated in over the past three months, another trial\n* The patient is participating in, or has participated in over the past three months, another study that may interfere with the results or conclusions of this study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, or is an adult under guardianship\n* It is impossible to correctly inform the patient\n* The patient refuses to sign the consent\n* The patient is pregnant, parturient or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug\n* Women\u002FMen refusing to use an effective contraception during and1 month after the last administration of study drug\n\nParticipant final exclusion criteria:\n\n* The patient refuses to participate to the study\n* The patient is pregnant, parturient or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug\n* Women\u002FMen refusing to use an effective contraception during and1 month after the last administration of study drug\n* Patients with diabetic foot wounds associated with clinical or radiographic signs of arthritis or osteomyelitis\\*\n* Patient is not infected by S. aureus or infected by more than 3 bacteria even if the culture isolates a S. aureus.",{"count":180,"type":22},60,[182,183],"PHASE1","PHASE2","The primary objective of this study is to compare the efficacy of standard treatment associated with a topical anti-staphylococcal bacteriophage cocktail versus standard treatment plus placebo for diabetic foot ulcers monoinfected by methicillin-resistant or susceptible S. aureus (MRSA or MSSA) as measured by the relative reduction in wound surface area (%) at 12 weeks.",[30,186],"Staphylococcal Infections",[188],"Phage Therapy","2026-03-18",{"date":191,"type":40},"2026-03-20",{"date":193,"type":22},"2026-09-01",{"date":195,"type":22},"2028-11",{"name":197,"class":47},"Centre Hospitalier Universitaire de Nīmes",6,{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":208,"conditions":209,"keywords":213,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"100452483","diabetic-foot-ulcer-dfu-biofilm-infection-and-recurrence-100452483","NCT05172089","Diabetic Foot Ulcer (DFU) Biofilm Infection and Recurrence","DFUBiofilm","Inclusion Criteria:\n\n* Male or Female, Age ≥ 18\n* Willing to comply with protocol instructions, including all study visits and study activities.\n* Patient with an open Diabetic Foot Ulcer\n* Adequate arterial blood flow as evidenced by at least one of the following (for wounds below the knee):\n* TcOM \\>30 mmHg\n* Ankle-brachial index at least ≥0.7\n* Toe pressure \\> 30 mmHg\n* TBI \\> 0.6 mmHg\n\nExclusion Criteria:\n\n* Individuals who are deemed unable to understand the procedures, risks, and benefits of the study.\n* Wounds closed or to be surgically closed by flap or graft coverage\n* Subjects with marked immunodeficiency (HIV\u002FAIDS, or on immunosuppressive medications.\n* TcOM \\\u003C 30mmHg\n* Diabetics with a hemoglobin A1c \\> 15 within 3 months prior to enrollment\n* Subject with autoimmune connective tissue disease\n* Ulcer size and location that does not allow the TEWL measurement per SOP\n* Pregnant women\n* Prisoners\n* Unable to comply with study procedures and\u002For complete study visits",{"count":207,"type":22},405,"This work is based on DFU patients, seeks to conduct a fully powered clinical study testing i) If DFU with a history of biofilm infection closes with deficient barrier function. ii) whether such functionally deficient wound closure, manifested as high TEWL, is associated with greater wound recurrence. The primary parent study will also address molecular mechanisms implicated in biofilm-induced loss of skin epithelial barrier integrity in DFU patients.",[63,210,211,30,212],"Biofilm Infection","Trans-epidermal Water Loss (TEWL)","Diabetic Foot Infection",[214,215,216,217],"foot ulcer","diabetic foot","wound infection","diabetic foot ulcer","2026-03-14",{"date":189,"type":40},{"date":221,"type":40},"2024-04-02",{"date":223,"type":22},"2029-06-27",{"name":225,"class":47},"University of Pittsburgh",2,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":48},"100628578","thermographic-camera-validation-for-diabetic-foot-assessment-hik-dm-2026-100628578","NCT07463456","Thermographic Camera Validation for Diabetic Foot Assessment (HIK-DM-2026)","Thermographic Camera Validation for Diabetic Foot Assessment","Inclusion Criteria:\n\n* Age 18 years and older.\n* Diagnosed with Type 1 or Type 2 Diabetes Mellitus.\n* Ability to understand and sign the informed consent.\n\nExclusion Criteria:\n\n* Active foot ulcers.\n* Recent surgery on the lower limbs.\n* Cognitive impairment that prevents following the study protocol.",{"count":235,"type":22},130,"This cross-sectional observational study validates the concordance of a low-cost thermographic camera (HIKMICRO Mini2 V2, \\~200 Euro) against a professional clinical standard (HIKMICRO M60) for diabetic foot assessment. Both cameras simultaneously capture plantar thermographic images from 130 participants with diabetes mellitus. Maximum contralateral thermal asymmetry (Delta T\\_max) across 6 plantar regions of interest (ROIs) is the primary endpoint, analyzed by intraclass correlation coefficient (ICC) and Bland-Altman method.",[30,238],"Diabetes Mellitus",[240,241,242,243,244,245,246,247],"thermography","infrared","concordance","ICC","low-cost","HIKMICRO","plantar temperature","diabetic foot screening","2026-03-10",{"date":250,"type":40},"2026-03-13",{"date":252,"type":22},"2026-04",{"date":254,"type":22},"2026-12",{"name":256,"class":47},"Universidad Europea de Canarias",{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":273,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"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":266,"type":22},272,[25],"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.",[270,271,30,272],"Diabetic Foot Ulcer (DFU)","Ulcer Foot","Foot Ulcer",[274,275,276],"Cellular, Acellular, Matrix-like Product (CAMP)","Cellular and\u002For Tissue Product (CTP)","Dehydrated Human Umbilical Cord (dHUC)","2026-02-26",{"date":279,"type":40},"2026-03-04",{"date":281,"type":22},"2026-07",{"date":283,"type":22},"2029-09",{"name":285,"class":84},"StimLabs",{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":305,"locationsCount":306},"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":266,"type":22},[25],"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.",[270,271,30,272],[274,275,299],"Dehydrated Complete Human Placental Membrane (dCHPM)",{"date":301,"type":40},"2026-03-02",{"date":303,"type":40},"2024-07-16",{"date":254,"type":22},{"name":285,"class":84},5,{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":48},"100605189","phase-4-a-multicenter-prospective-controlled-clinical-trial-evaluating-the-efficacy-of-a-single-layer-placental-based-allograft-and-standard-of-care-in-the-management-of-nonhealing-diabetic-foot-ulcers-100605189","NCT07159282","A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers","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* If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the CAMPX study.\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* The potential subject must have participated in the CAMPX trial in the SOC only arm and NOT achieved complete closure by the 12-week endpoint.\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* There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\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 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, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n* The potential subject did not participate in the CAMPX trial.\n* The potential subject participated in the CAMPX trial and was not randomized to the SOC only arm.\n* The potential subject participated in the CAMPX trial and achieved complete closure.",{"count":180,"type":22},[315],"PHASE4","A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.",[30,272,271,318,319,320,31],"DFU","Foot Ulcer Due to Type 2 Diabetes Mellitus","Foot Ulcer Due to Type 1 Diabetes Mellitus","2026-02-09",{"date":323,"type":40},"2026-02-11",{"date":325,"type":40},"2025-08-26",{"date":327,"type":22},"2027-08",{"name":329,"class":84},"Applied Biologics, LLC",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":348,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":48},"100525657","early-percutaneous-transluminal-angioplasty-in-diabetic-foot-syndrome-pta-dfs-100525657","NCT06124586","Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)","Role of Percutaneous Transluminal Angioplasty for Wound Healing and Dynamics of the Microbial Community in Patients With Type 2 Diabetes and Diabetic Foot Syndrome","PTA-DFS","Inclusion Criteria:\n\n* volunteer adults\n* written informed consent\n* presence of known manifest T2D and fulfilment of the following criteria:\n* HbA1c \\\u003C 10%\n* presence of pAVD with fulfillment of the following criteria:\n* PAD Stage After Fontaine IV (foot ulcer)\n* Presence of foot ulcer with fulfillment of the following criteria:\n* Foot ulceration without indication for emergency surgical care from stage Wagner 1.\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Acute leg ischemia (sudden onset, sensorimotor deficits, pale extremity, pain, loss of pulse, and shock).\n* Type 1 diabetes mellitus (GADA, ICA, IA-2A, ZnT8A positive).\n* Minors or subjects incapable of giving consent\n* Pregnant or breastfeeding women\n* Treatment with certain drugs (immunosuppressive therapy,\n* Immunomodulators, chemotherapy, antibiotic therapy \\\u003C 2 weeks before\n* intervention)\n* Diseases of the pancreas\n* Severe neurological or psychiatric disease\n* Known presence of malignant tumor disease within the past 5 years\n* Participation in other interventional trials and receipt of investigational medication within the last 30 days\n* Blood or plasma donation within the last 3 months",{"count":339,"type":22},200,[25],"The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in percutaneous transluminal angioplasty (PTA) readiness (\"immediate\" treatment, within 48h) has advantages over the \"standard of care\", i.e., an elective procedure (\"elective PTA\") for the treatment of diabetic foot ulcer (DFU). The primary study endpoint is to investigate the impact of the \"early PTA\" within 48 hours on wound-healing assessed by wound area changes after PTA using a 3D-camera with artificial intelligence (AI)-based wound-analysis-system. The secondary endpoint is the effect of early PTA on the combined occurrence of major adverse limb (MALE) and cardiac events (MACE) over 12 months post-angioplasty using time-to-event analysis. Data will be collected at baseline, 24 hours, 1, 2, 3, 6, and 12 months after PTA. Diabetic kidney disease, distal symmetric polyneuropathy, retinopathy, cardiomyopathy, laboratory analyses, clinical scores, AI-based fundus photography, echocardiography, duplex sonography, and pulse oscillography will be assessed. Explanatory variables for wound healing are wound microbiome changes using whole-genome sequencing and oxygen saturation of the wound environment measured using near-infrared spectroscopy. Altered microbiome composition in ulcers can lead to severe local and systemic infections and complications, including major amputations. Nevertheless, the specific significance of the wound microbiome composition in chronic ischaemic ulcers in type 2 diabetes and the impact of PTA on the wound microbiome in type 2 diabetes is unclear. The exact timing for treating peripheral arterial disease (PAD) by revascularization in DFU after initial diagnosis is unknown and has yet to be fully understood.",[30,238,155,343,344,345,271,346,347],"Diabetic Neuropathies","Diabetic Retinopathy","Anemia","Ulcer Ischemic","Diabetic Polyneuropathy",[349,350,351,352,353],"diabetic foot syndrome","peripheral artery disease","diabetic food ulcers","microbiome","percutaneous transluminal angioplasty","2026-02-03",{"date":356,"type":40},"2026-02-04",{"date":358,"type":40},"2024-02-01",{"date":360,"type":22},"2028-11-01",{"name":362,"class":47},"Heinrich-Heine University, Duesseldorf",{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":372,"conditions":373,"keywords":374,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":385},"100524149","dfc-004-biomarkers-for-active-diabetic-foot-ulcers-100524149","NCT06104969","DFC 004 Biomarkers for Active Diabetic Foot Ulcers","Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers: Open Wound Master Study","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Age 18 years or older.\n3. Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria. \\[ADA Standards of Clinical Care Diabetes Care 2022, Suppl 1\\]\n4. Open foot ulcer, defined as an open wound from malleolus down. This includes post-surgical wounds within this area left open to heal by secondary intention. In case of multiple ulcers, the largest ulcer will be considered the study index DFU.\n5. Agreement to adhere to protocol visits and provide all required biospecimens and clinical data.\n\nExclusion Criteria:\n\n1. Participation in an interventional clinical trial for DFU within 1 month of Visit 1.\n2. Currently receiving radiation to target area or chemotherapy.\n3. Gangrene in any portion of the foot with the index ulcer.\n4. Planned revascularization or under evaluation for revascularization of the index limb for advanced ischemia within next 4 weeks of Week 0.\n5. Severe limb ischemia (SVS WIfl Ischemia grade 3).\n6. Any concomitant medical or psychiatric condition that, in the opinion of the investigator(s), would compromise the participant's ability to safely complete the study.",{"count":371,"type":22},5000,"This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound healing interventions",[31,30,28],[217,375],"Diabetic Foot Consortium","2025-09-08",{"date":378,"type":40},"2025-09-15",{"date":380,"type":40},"2023-06-15",{"date":382,"type":22},"2028-06-15",{"name":384,"class":47},"University of Michigan",8,{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":394,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":413},"100495225","effectiveness-of-remote-foot-temperature-monitoring-100495225","NCT05728411","Effectiveness of Remote Foot Temperature Monitoring","Home Foot-temperature Monitoring Through Smart Mat Technology to Improve Access, Equity, and Outcomes in High-risk Patients With Diabetes","STOP","Inclusion Criteria:\n\n* Veteran\n* Diabetes diagnosis\n* History of foot ulcer (including active ulcer) OR history of lower extremity amputation (including unhealed amputation)\n* Able to understand\u002Fread English\n\nExclusion Criteria:\n\n* Dementia\n* Unable to ambulate\n* Bilateral lower extremity amputation\n* Ankle brachial index \\\u003C0.6 or toe brachial index \\\u003C0.5\n* Currently using in-home temperature monitoring\n* Prisoner","89 Years",{"count":396,"type":22},800,[25],"Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural Veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poor because the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a \"smart\" mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.",[30],[215,401,402],"Dept. of Veterans Affairs","remote sensing technology","2025-09-04",{"date":405,"type":40},"2025-09-11",{"date":407,"type":40},"2023-10-02",{"date":409,"type":22},"2031-12-31",{"name":411,"class":412},"VA Office of Research and Development","FED",4,{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":48},"100527988","immune-cells-in-diabetic-chronic-foot-ulcers-100527988","NCT06154915","Immune Cells in Diabetic Chronic Foot Ulcers","Characterise the Immunological Response of Diabetic Patients With Chronic Foot Ulcers","Inclusion Criteria:\n\n* diabetes with diabetic foot ulcer\n\nExclusion Criteria:\n\n* impaired cognitive function\n* on-going immune suppressive treatment\n* diagnosed active cancer\n* cancer treatment\n* known chronic inflammatory disease","98 Years",{"count":423,"type":22},40,"The goal of this observational study is to learn about the role of immune cells in patients with diabetes and chronic foot ulcers. Researchers will compare blood and tissue samples of patients with diabetes and a foot ulcer that is healing or healed compared to those diabetic patients where the foot ulcers is not healing (chronic ulcer).",[30,426],"Immune Defect",{"date":428,"type":40},"2025-09-03",{"date":430,"type":40},"2022-09-09",{"date":432,"type":22},"2029-12-31",{"name":434,"class":47},"Karolinska Institutet",{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":445,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":48},"100599831","phase-4-trial-assessing-the-efficacy-of-human-placental-membrane-products-and-standard-of-care-versus-standard-of-care-alone-in-the-management-of-nonhealing-diabetic-foot-ulcers-and-venous-leg-ulcers-100599831","NCT07089602","Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers","A Multicenter, Prospective, Randomized Controlled Modified Multi- Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers","BIOCAMP","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 20 cm2 measured post debridement with the eKare inSight® imaging device.\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.\n* 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 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: DFU\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* There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\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 is taking hydroxyurea.\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 40% in the 4 weeks prior to Treatment Visit 1 (\"historical\" run-in period\\*). OR 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 AND 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 (SV1) to the TV-1 visit.\n\n  a. eKare inSight® 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 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 indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n\nInclusion Criteria:VLU\n\n* The potential subject must be at least 21 years of age or older.\n* At enrollment, the potential subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.\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'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.\n* If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\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 infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n* The potential subject's target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the potential subject's 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 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 40% in the 4 weeks prior to Treatment Visit 1 (\"historical\" run-in period\\*). OR 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 AND 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 (SV1) to the TV-1 visit.\n\n  a. \\*eKare inSight® 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 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* A potential subject who, 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 indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n* The potential subject has a wound with active or latent infection.\n* The subject has a disorder that would create unacceptable risk of post-operative complication.",{"count":444,"type":22},650,[315],"The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.",[30,318,31,448,271,449,450,451,452],"Foot Ulcer, Diabetic","Venous Leg Ulcer","Leg Ulcer","Leg Ulcers Venous","Ulcer","2025-07-24",{"date":455,"type":40},"2025-07-28",{"date":457,"type":40},"2025-07-15",{"date":459,"type":22},"2027-07",{"name":461,"class":84},"BioLab Holdings",{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":470,"targetDuration":472,"studyType":152,"phases":4,"briefSummary":473,"conditions":474,"keywords":491,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":48},"100230679","a-real-world-registry-of-chronic-wounds-and-ulcers-100230679","NCT02280733","A Real-World Registry of Chronic Wounds and Ulcers","A Longitudinal, Real World, Observational Registry of Chronic Wounds and Ulcers and the Patients Who Have Them","WOUNDJOURNEY","Inclusion Criteria:\n\n* Presence of one or more chronic wounds or ulcers of any etiology\n* Wound or ulcer must be treated at a participating site (which can be a hospital outpatient department, office, mobile practitioner, in the home setting, skilled nursing, etc.)\n* Care must be documented using the purpose-built, wound-specific structured electronic health record (EHR) or electronic data capture (EDC) system\n* All ages, including infants and patients aged 90 years or older (reported in aggregate in accordance with HIPAA de-identification standards)\n* All sexes and gender identities\n* All wound types and severities, including multiple wounds per patient\n\nExclusion Criteria:\n\n-None (the registry includes all eligible patients treated at participating sites without sampling or exclusion criteria)",{"count":471,"type":22},300000,"5 Years","WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic health record (EHR) or electronic data capture (EDC) system. Data are transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry captures real-time, research-ready data on patient demographics, comorbidities, wound characteristics, standard-of-care treatments, complications, and advanced therapeutics. It supports robust, fit-for-purpose real-world evidence generation by enabling risk-adjusted outcome analysis, comparative effectiveness research, and quality improvement across diverse sites of care.",[30,475,476,477,478,450,479,155,480,481,482,483,484,485,62,486,487,488,489,490],"Pressure Ulcer","Surgical Wound Dehiscence","Vasculitis","Skin Ulcer","Pyoderma","Lymphedema","Surgical Complication","Venous Leg Ulcers (VLUs)","Calciphylaxis","Sickle Cell Ulcer","Pressure Ulcer (PU)","Pressure Injury","Arterial Ulcers","Soft Tissue Radionecrosis (STRN)","Traumatic Wounds","Chronic Ulcer",[492,493,494,495,496,497,31,449,475,486,498,499,481,500,70,501,502,503,504,505,506,507,508,509,510,511,512,513,514,75,515],"Qualified Clinical Data Registry","Quality Measures","Clinical Data Research Network","Real world data","chronic wounds","chronic ulcers","Arterial Ulcer","Traumatic Wound","Pyoderma Gangrenosum","Skin Substitutes","CAMPs","CTPs","Negative Pressure Wound Therapy","NPWT","Collagen Dressings","Compression Therapy","Hyperbaric Oxygen Therapy","Wound Debridement","Real-World Evidence","Comparative Effectiveness","Wound Healing","Amputation","Electronic Health Record (EHR)","Standard of Care","2025-07-10",{"date":518,"type":40},"2025-07-16",{"date":520,"type":40},"2005-01-01",{"date":522,"type":22},"2030-01",{"name":524,"class":47},"U.S. Wound Registry",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":532,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":549},"100553568","evaluating-a-lifestyle-intervention-to-prevent-recurrence-of-diabetic-foot-ulcers-100553568","NCT06487780","Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers","Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers: A Pilot Study","Inclusion Criteria:\n\n* Age \\>= 21 years\n* Healed diabetic foot ulcer within the past twelve months\n* Able to walk independently (use of a cane is acceptable)\n\nExclusion Criteria:\n\n* Current active diabetic foot ulcer\n* History of amputation beside toe or part of the foot\n* Non-ambulatory at baseline\n* Self-reported deafness\u002Fblindness.","21 Years",{"count":180,"type":22},[25],"People with diabetes often experience foot ulcers, which can harm their ability to move, lower their quality of life, and increase the chances of losing a limb. These diabetic foot ulcers (DFUs) commonly come back (recur) even after they've healed, so it's crucial to stop them from returning to avoid toe, foot , or leg amputation. While wearing special shoes to reduce pressure on the feet is essential for healing and preventing DFUs, many people struggle to follow this treatment plan once their ulcers have healed. This study aims to see if a lifestyle-focused program can help participants create daily routines and habits that make it easier to consistently use special shoes and take care of their diabetes and feet to prevent ulcers from recurring.",[30,31,448,537],"Foot Wound",[539],"Diabetic foot ulcer, lifestyle intervention","2025-06-20",{"date":542,"type":40},"2025-06-22",{"date":544,"type":40},"2025-06-11",{"date":546,"type":22},"2026-06-30",{"name":548,"class":47},"University of Southern California",3,{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":557,"sex":18,"minAge":19,"maxAge":558,"enrollmentInfo":559,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":560,"conditions":561,"keywords":563,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":48},"100432849","the-role-of-skin-microecology-in-diabetic-skin-lesions-100432849","NCT04916457","The Role of Skin Microecology in Diabetic Skin Lesions","Explore the Role of Skin Microecology in Diabetic Skin Lesions Based on Multi-omics Data Analysis","Inclusion Criteria:\n\n1\\. Surface skin cotton swab collection\n\n(1) Observation group: In the endocrinology department of Nanfang hospital, the patient were diagnosed with type 2 diabetes to the WHO 1999 diagnostic criteria for diabetes.\n\n(2) Control group:\n\n1. Control subjects that was ruled out diabetes according to the WHO 1999 diagnostic criteria for euglycemia.\n2. Age ≥18 years, the patient and (or) his family members know and agree to participate in this study.\n\n2\\. Skin tissue collection\n\n(1) Observation group:\n\n1. The patient was diagnosed with type 2 diabetes in the Endocrinology Department, Burns Department, Traumatology Orthopedics, Plastic Surgery in Nanfang hospital.\n2. Patients who need surgical operations such as debridement and amputation below the knee joint due to various reasons such as diabetic foot osteomyelitis, fractures, car accidents and so on.\n\n(2) Control group:\n\n1. The patient without type 2 diabetes in the Endocrinology Department, Burns Department, Traumatology Orthopedics, Plastic Surgery in Nanfang hospital.\n2. Patients who need surgical operations such as debridement and amputation below the knee joint due to various reasons such as post-traumatic foot osteomyelitis, fractures, car accidents and so on.\n3. Age ≥18 years, the patient and (or) his family members know and agree to participate in this study.\n\nExclusion Criteria:\n\nThe patients Including other skin diseases, using medically prescribed soap for bathing, using cosmetics on the feet, suffering from severe liver and kidney disease, immune system disease, HIV infection, malignant tumors, or using immunosuppressive drugs within the first four weeks. The patient or (and) their family members refused to participate in this study.\n\nThe researchers judged that they are not suitable to participate in this research.",true,"80 Years",{"count":339,"type":22},"This study is an observational study. Collect cotton swabs of the surface skin are obtained from the non-diabetic and diabetic patients hospitalized in the Nanfang Hospital of Southern Medical University. The investigators use omics technology to identify the structure and functions of cutaneous microbiome, analyze the characteristics of the skin flora of diabetic patients, and find the difference in skin microbiota among diabetic patients with different risk levels for developing into diabetic foot. Then, the participants will be followed up to compare the incidence of ulcers among different groups. And the skin tissues discarded during surgical operations of non-diabetic and diabetes patients are collected for pathological examination. Finally, based on the results of 16S high-throughput sequencing, metagenomics, etc., specific flora could be extracted from human skin flora cotton swabs, and animal experiments are performed to explore the effect of skin micro-ecology on diabetic skin lesions. The investigators will explore in animal experiments to regulate the influence of skin micro-ecology on diabetic skin lesions through treatment methods such as different hypoglycemic drugs and probiotic emulsions.",[30,562],"Diabetic Dermopathy",[103,564],"skin micro-ecology","2025-06-03",{"date":567,"type":40},"2025-06-06",{"date":569,"type":40},"2020-12-18",{"date":571,"type":22},"2026-07-31",{"name":573,"class":47},"Nanfang Hospital, Southern Medical University",{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":557,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":549},"100592114","multi-modal-quantitative-imaging-of-the-skin-100592114","NCT06989216","Multi-modal Quantitative Imaging of the Skin","DermaFlow Alpha - Multi-modal Quantitative Imaging of the Skin","DermaFlow","Inclusion criteria:\n\n* Adult patients that are part of the regular healthcare patient flow at the investigational sites, or as separately invited to participate in this investigation.\n* Patients with signed informed consent\n\nExclusion criteria:\n\n* Cognitive impairment\n* Patients unable to understand the oral and written study information in Swedish or English\n* Other severe disorder or terminal disease\n* Patients unable to provide an informed consent\n* Patients not able to keep balance, while standing up with closed eyes, without any aid\n* Claustrophobic patients",{"count":583,"type":22},8000,"This clinical trial is about evaluating the suitability of multi-modal imaging technology, which covers virtually the entire body, to evaluate the possibility of screening and early detection of disease.",[586,587,588,589,590,30,155],"Skin Cancer","Skin Diseases","Atopic Dermatitis","Psoriasis","Raynaud Disease","2025-05-16",{"date":593,"type":40},"2025-05-25",{"date":595,"type":40},"2023-02-01",{"date":597,"type":22},"2026-02-01",{"name":599,"class":84},"HJN Sverige AB\u002FNeko Health",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":18,"minAge":532,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":23,"phases":609,"briefSummary":610,"conditions":611,"keywords":612,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":624,"locationsCount":48},"100537523","adapting-lifestyle-offloading-for-dfus-100537523","NCT06278935","Adapting Lifestyle Offloading for DFUs","Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers","Inclusion Criteria:\n\n* English speaking\n* Age 21 years or older\n* History of active DFU necessitating offloading\n* Capacity to provide informed consent\n* Access to telehealth (internet connection and equipment)\n* Ability to walk independently or with an assistive device\n* Self-reported life expectancy of more than one year\n\nExclusion Criteria:\n\n* Self-reported deafness or blindness\n* history of lower extremity amputation besides toes",{"count":608,"type":22},20,[25],"The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention.",[31,30],[613,614,615,616,617],"Offloading diabetic foot ulcer","Lifestyle-focused intervention","Occupational therapy","Occupational therapist","Self management","2025-05-13",{"date":620,"type":40},"2025-05-18",{"date":622,"type":40},"2025-02-10",{"date":252,"type":22},{"name":548,"class":47},{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":629,"acronym":630,"eligibilityCriteria":631,"healthyVolunteers":557,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":633,"conditions":634,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":639,"completionDateStruct":640,"leadSponsor":642,"locationsCount":549},"100591103","non-invasive-imaging-for-in-vivo-quantification-of-skin-composition-and-structure-100591103","NCT06976073","Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure","Spectrum1","Inclusion Criteria:\n\n* Adult patients part of the regular healthcare patient flow at the investigational sites, or as separately invited to participate in this investigation.\n* Patients with signed informed consent\n\nExclusion Criteria:\n\n* Cognitive impairment\n* Patients unable to understand the oral and written study information in Swedish or English\n* Other severe disorder or terminal disease\n* Patients unable to provide an informed consent\n* Patient´s with damaged, scarred or non-intact skin within the skin area of interest.",{"count":583,"type":22},"The goal of this clinical investigation is to explore a non-invasive technology for measuring the microcirculatory structure, composition and function in patients from a primary care population.\n\nThe main aims are:\n\n1. To evaluate the robustness of the technology for assessment of the molecular composition and structure of the skin tissue and microcirculatory function, on a prospective primary care population.\n2. To evaluate the device and method on its capability to detect deficiencies in circulation, compared with existing reference systems with similar characteristics for patients with known cardiovascular disease risk and\u002For diabetes.",[635,30,155,586,636],"Diabetes Mellitus, Type 2","Cardiovascular Disease Risk","2025-05-08",{"date":591,"type":40},{"date":595,"type":40},{"date":641,"type":22},"2026-01-01",{"name":599,"class":84},{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":647,"acronym":648,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":650,"enrollmentInfo":651,"targetDuration":4,"studyType":23,"phases":653,"briefSummary":654,"conditions":655,"keywords":656,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":662,"leadSponsor":664,"locationsCount":48},"100522548","path-active-multicentre-randomised-controlled-trial-previous-pilot-path-active-safety-and-tolerability-study-100522548","NCT06084052","Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)","PAMRCT","Inclusion Criteria:\n\n* • Participant able to give informed consent.\n* Age \\>18 at the time of consent.\n* Diagnosis of Type 1 or Type 2 Diabetes.\n* Both Feet Intact (no ulceration).\n* Participant understands and is willing to participate and can comply with the follow-up regime.\n* Participant diabetes foot Risk Stratification as 'High Risk' as in Frame (2021) Scotland\u002FEngland https:\u002F\u002Fwww.diabetesframe.org\u002F\n* Ability to walk independently for \\> 100 metres i.e without use of wheelchair, walking stick or personal assistance.\n* Participant able and willing to wear suitable footwear.\n* Must own a mobile phone and be willing to upload WWP app.\n\nExclusion Criteria:\n\n* Either foot has less than 2 arterial vessel run-off on Doppler.\n* Poor visual acuity ie registered blind, unless supported by carer.\n* Current participation in another clinical investigation of a medical device or a drug; or participation in such a study within 30 days prior to study enrolment.\n* Body Mass Index (BMI) \\>40.\n* Participant has bespoke contact insoles and footwear.\n* Participant is unable to use 'medium' or 'large' insoles due to foot size eg. small or extra large feet.\n* Participant has a pacemaker.\n* Participant is pregnant.","100 Years",{"count":652,"type":22},120,[25],"Path Active™ comprises a pair of monitoring insoles which measure parameters associated with foot ulceration in diabetes: temperature and pressure. The insoles are linked via an app to the wearer's mobile phone and also to a clinical dashboard so that both wearer and clinician are alerted to early signs of skin damage on the foot so that immediate preventive action can be taken. The study is a multisite randomised controlled trial which will evaluate the effectiveness of Path Active™ in 60 people with diabetes who are at 'high risk' of foot ulceration, compared with 60 people who receive their usual podiatry foot checks over a period of 12 weeks.",[30],[657],"Foot Ulcer Prevention","2025-04-11",{"date":660,"type":40},"2025-04-15",{"date":221,"type":40},{"date":663,"type":22},"2026-03-31",{"name":665,"class":47},"Royal Free Hospital NHS Foundation Trust",{"id":667,"slug":668,"hasResults":12,"nctId":669,"briefTitle":670,"officialTitle":671,"acronym":672,"eligibilityCriteria":673,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":674,"enrollmentInfo":675,"targetDuration":4,"studyType":23,"phases":676,"briefSummary":677,"conditions":678,"keywords":684,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":688,"lastUpdatePostDateStruct":689,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":695,"locationsCount":226},"100331368","additional-hyperbaric-oxygen-after-lower-extremity-amputation-100331368","NCT03594344","Additional Hyperbaric Oxygen After Lower Extremity Amputation","Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial","AHOLEA","Inclusion Criteria:\n\n* Lower extremity amputation because of chronic wound, osteomyelitis, ischemia, necrosis.\n* Fit to receive hyperbaric oxygen therapy determined by an anesthesiologist\u002FHyperbaric Medicine Physician.\n* Able to cooperate and follow up appointments\n* Included within 7 days after final surgery\n\nExclusion Criteria:\n\n* Not fulfilling inclusion criteria\n* Pregnancy\n* Dementia","90 Years",{"count":652,"type":22},[25],"This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or control group.",[238,679,680,681,513,682,683,343,30],"Claudication, Intermittent","Critical Limb Ischemia","Osteomyelitis","Lower Extremity Ulcer","Diabetic Angiopathy",[103,28,685,686,687],"Lower extremity amputation","Hyperbaric oxygen therapy","HBOT","2025-03-25",{"date":690,"type":40},"2025-03-30",{"date":692,"type":40},"2018-07-04",{"date":694,"type":22},"2026-12-31",{"name":696,"class":47},"Oslo University Hospital",{"id":698,"slug":699,"hasResults":12,"nctId":700,"briefTitle":701,"officialTitle":702,"acronym":4,"eligibilityCriteria":703,"healthyVolunteers":12,"sex":18,"minAge":532,"maxAge":4,"enrollmentInfo":704,"targetDuration":4,"studyType":23,"phases":706,"briefSummary":707,"conditions":708,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":711,"lastUpdatePostDateStruct":712,"startDateStruct":714,"completionDateStruct":716,"leadSponsor":718,"locationsCount":48},"100579595","phase-4-evaluating-several-cellular-acellular-and-matrix-like-products-camps-and-standard-of-care-versus-standard-of-care-alone-in-the-management-of-nonhealing-diabetic-foot-and-venous-leg-ulcers-100579595","NCT06826339","Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.","A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.","Inclusion Criteria:(DFU)\n\n* Subjects The potential subject must be at least 21 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 20.0 cm2 measured post debridement.\n* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks and a maximum of 52 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.\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.\n* If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. The potential subject must have a target ulcers located on the plantar aspect of the foot 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: (DFU)\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 potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n* The potential subject's target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the potential subject's 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). EKare 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 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) 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* A potential subject who, 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 indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n* The potential subject has a wound with active or latent infection.\n* The potential subject has a disorder that would create unacceptable risk of post-operative complication.\n\nInclusion Criteria:(VLU)\n\n* The potential subject must be at least 21 years of age or older.\n* At enrollment, the potential subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.\n* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.\n* The potential subject has no visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.\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.\n* If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\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: (VLU)\n\n* The potential subject is known to have a life expectancy of \\\u003C 6 months.\n* The potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n* The potential subject's target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the potential subject's 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 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). EKare 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 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.\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* A potential subject who, 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 indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n* The potential subject has a wound with active or latent infection.\n* The subject has a disorder that would create unacceptable risk of post-operative complication.",{"count":705,"type":22},340,[315],"Title A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care versus Standard of Care alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.",[449,709,30,31,448,271,450,710,452],"Venous Leg","Ulcer Venous","2025-02-12",{"date":713,"type":40},"2025-02-13",{"date":715,"type":40},"2024-12-06",{"date":717,"type":22},"2027-12",{"name":719,"class":84},"Tiger Biosciences, LLC."]