[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-foot-ulcer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-foot-ulcer":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,78,0,25,[9,39,69,92,122,144,172,199,221,244,271,298,324,345,374,395,422,443,463,489,515,540,556,583,606],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100616019","feetsee-thermal-images-collection-protocol-in-diabetes-patients-100616019",false,"NCT07300163","FeetSee Thermal Images Collection Protocol in Diabetes Patients","Foot Temperature and Diabetic Foot Ulcer Risk: Using the FeetSee Device to Generate a Unique Foot Temperature Dataset.","Inclusion Criteria:\n\n* Males\u002Ffemales aged over 18 years.\n* Type 1 or type 2 diabetes.\n* History of plantar diabetic foot ulcer(s).\n* Foot ulcer healed for at least 6 weeks before entry into study, as determined by a specialist healthcare provider.\n* Presence of diabetic peripheral neuropathy defined by either of the following:\n\n  * Inability to detect the monofilament (10g) applied at two foot sites, including the apex of the Hallux (ADA guidelines 2008 Diabetes Care 31(1)).\n  * A Vibration Perception Threshold (VPT) \\>20V, and\u002For by inability to detect application of the monofilament at the apex of the Hallux.\n* Presence of at least one palpable foot pulse.\n\nExclusion Criteria:\n\n* Active foot ulceration.\n* Active Charcot neuro-osteoarthropathy.\n* Severe vascular disease (complete absence of any foot pulses).\n* Lower limb\u002Ffoot amputation greater than metatarsophalangeal disarticulation.\n* Active malignancy, immunosuppressive disease.\n* Physical or mental condition(s) that limit the ability to follow instructions for the study, based on clinical judgment by the physician, such as inability to use the device without assistance.\n* Current participation in another clinical investigation of a medical device that is contraindicated for either study procedure\u002Foutcome.","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","Diabetic foot ulcers (DFUs) are a major cause of morbidity, lower-extremity amputation and healthcare costs in people with diabetes. DFUs often develop without pain or warning symptoms because of diabetic peripheral neuropathy, so patients may not recognise early signs of tissue damage. Monitoring plantar foot skin temperature is a promising strategy to detect early \"hot-spots\" of inflammation that precede ulceration and could trigger timely preventive action.\n\nThis prospective, single-group study will enrol adults with type 1 or type 2 diabetes, a history of plantar DFU that has been healed for at least 6 weeks, and evidence of diabetic peripheral neuropathy. Participants will be recruited from hospital clinics in the United Kingdom and Lithuania. After a baseline assessment (including medical history and neuropathy testing), each participant will receive the FeetSee system, consisting of a thermal camera attached to their own smartphone or tablet, a stand, and the FeetSee mobile application.\n\nParticipants will be instructed to acquire thermal and optical images of both feet at home at least once per day for 6-9 months, or until a new DFU develops. Images will be uploaded securely to cloud storage, where the FeetSee algorithm will analyse temperature patterns, comparing mirrored regions of both feet to identify potential inflammatory \"hot-spots\" associated with DFU risk. Participants will continue to receive standard clinical care throughout the study.\n\nThe primary objective is to generate a longitudinal foot temperature dataset in this high-risk population and use it to retrospectively test and refine the FeetSee algorithm for predicting DFU occurrence. The primary outcome is the incidence of new DFUs during follow-up. Secondary objectives are to assess the feasibility and acceptability of daily device use (recruitment, retention, adherence, user and healthcare-provider questionnaires) and to document any device-related or system-related safety issues.",[25],"Diabetic Foot Ulcer","RECRUITING","2026-06-18",{"date":29,"type":30},"2026-06-22","ACTUAL",{"date":32,"type":30},"2025-12-16",{"date":34,"type":21},"2027-05-30",{"name":36,"class":37},"Diabetis JSC","INDUSTRY",4,{"id":40,"slug":41,"hasResults":12,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100588229","evaluating-the-efficacy-neothelium-ft-in-the-treatment-of-diabetic-foot-ulcers-100588229","NCT06938685","Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers","Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Multicenter Crossover Trial","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and\u002For insulin replacement therapy\n3. Subject has a diabetic foot ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC\n4. Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening\n5. Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization\n6. Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior to screening.\n7. Index ulcer is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit\n8. Diabetic foot ulcer is being treated with offloading therapy for 14 days prior to randomization\n9. Adequate circulation of ulcer demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.\n10. Index ulcer is free of infection prior to randomization and during screening phase. Infection must be adequately treated and controlled as defined by Infectious Disease Society of America (IDSA) Guidelines PEDIS Grade 1.\n11. Index ulcer is free of necrotic debris prior to NeoThelium FT application\n12. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n13. Subject is able and willing to follow the protocol requirements\n14. Subject had signed informed consent\n15. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject has a known life expectance of \\\u003C1 year\n2. Subject is unable to comply with protocol treatment\n3. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing\n4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n6. Known contraindications to tissue-engineered allograft\n7. Concurrent participation in alternative clinical trial that involves investigational drug or device interfering with wound treatment and\u002For healing\n8. Subject is pregnant or breastfeeding\n9. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study\n10. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization\n11. Diabetic foot ulcer of Wagner 3 grade with active acute infection that has not completed IV antibiotic treatment, or Wagner 3 grade with chronic refractory osteomyelitis\n12. Wound depth with visible exposed bone\n13. HBOT within 14 days prior to randomization\n14. Revascularization surgery on the index ulcer leg within 30 days of screening phase\n15. Index ulcer suspicious of neoplasm in the opinion of the principal investigator",{"count":47,"type":21},132,"INTERVENTIONAL",[50],"NA","This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot ulcers.",[25],[54,55,56,57,58],"Chronic wounds","Wound Medicine","Cellular, Acellular, Matrix-like Product (CAMP)","Cellular and\u002For Tissue Product (CTP)","Dehydrated Complete Human Placental Membrane (dCHPM)","2026-06-15",{"date":61,"type":30},"2026-06-17",{"date":63,"type":30},"2025-10-06",{"date":65,"type":21},"2026-10-01",{"name":67,"class":37},"NuScience Medical Biologics, LLC",8,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":48,"phases":78,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100605385","evaluating-the-efficacy-of-ocm-omeza-complete-matrix-in-the-treatment-of-diabetic-foot-ulcers-100605385","NCT07161830","Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers","Evaluation of the Efficacy of Omeza® Complete Matrix in the Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Multicenter Crossover Trial","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and\u002For insulin replacement therapy\n3. Subject has a diabetic foot ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC\n4. Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening\n5. Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization\n6. Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior to screening.\n7. Index ulcer is a minimum of 0.7cm2 and a maximum of 25cm2 at first treatment visit\n8. Diabetic foot ulcer is being treated with offloading therapy for 14 days prior to randomization\n9. Adequate circulation of ulcer demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.\n10. Index ulcer is free of infection prior to randomization and during screening phase. Infection must be adequately treated and controlled as defined by Infectious Disease Society of America (IDSA) Guidelines PEDIS Grade 1.\n11. Index ulcer is free of necrotic debris prior to OCMTM application\n12. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n13. Subject is able and willing to follow the protocol requirements\n14. Subject had signed informed consent\n15. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject has a known life expectance of \\\u003C1 year\n2. Subject is unable to comply with protocol treatment\n3. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing\n4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n6. Known contraindications to Acellular matrices\n7. Concurrent participation in alternative clinical trial that involves investigational drug or device interfering with wound treatment and\u002For healing\n8. Subject is pregnant or breastfeeding\n9. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study\n10. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization\n11. Diabetic foot ulcer of Wagner 3 grade with active acute infection that has not completed IV antibiotic treatment, or Wagner 3 grade with chronic refractory osteomyelitis\n12. Wound depth with visible exposed bone\n13. HBOT within 14 days prior to randomization\n14. Revascularization surgery on the index ulcer leg within 30 days of screening phase\n15. Index ulcer suspicious of neoplasm in the opinion of the principal investigator",{"count":77,"type":21},130,[50],"This study aims to compare two treatment approaches for diabetic foot ulcers (DFUs): the standard of care (SOC) alone versus SOC combined with OCM. Researchers will evaluate whether adding OCM increases the likelihood of ulcers healing completely by the end of the trial period.",[25],[82,55],"Chronic Wounds","2026-06-12",{"date":59,"type":30},{"date":86,"type":30},"2025-12-04",{"date":88,"type":21},"2027-03-30",{"name":90,"class":37},"Omeza, LLC",10,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":17,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":48,"phases":102,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100575326","implementation-of-a-preventive-diabetic-foot-care-program-for-patients-at-risk-of-diabetic-foot-100575326","NCT06770829","Implementation of a Preventive Diabetic Foot Care Program for Patients at Risk of Diabetic Foot","The Effect of a Preventive Diabetic Foot Care Program on Knowledge, Behavior, Self-Management, and Glycemic Control Levels in Patients at Risk of Diabetic Foot","Inclusion Criteria\n\nParticipants must meet all of the following criteria to be included in the study:\n\n* Patients with type 2 diabetes receiving follow-up and treatment at the Akdeniz University Hospital Endocrinology and Metabolic Diseases Outpatient Clinic.\n* Presence of one or more diabetic foot risk factors, categorized as category 2 or 3 according to the IWGDF (International Working Group on the Diabetic Foot) Risk Classification System.\n* Diagnosed with type 2 diabetes for at least six months.\n* Aged between 30 and 65 years.\n* Literate.\n* No physical or mental disabilities that would prevent answering the study questions.\n* No communication barriers.\n* Able to understand and verbalize their diagnosis.\n* HbA1c ≥7.5%.\n* Internet access at home and possession of a device such as a computer, tablet, or smartphone, with the ability to use these tools.\n* Willing to provide informed consent to participate in the study.\n\nExclusion Criteria\n\nParticipants will be excluded if they meet any of the following conditions:\n\n* Myocardial infarction, stroke, heart failure, or angina pectoris within the last year.\n* Diagnosed with type 1 diabetes or gestational diabetes.\n* Presence of an active diabetic foot ulcer.\n* Diagnosed with dementia or cognitive deficits.\n* Diagnosed with glaucoma, cataracts, or retinopathy.\n* Diagnosed with a terminal illness.\n* Inability to provide accurate information or participate in the study.\n\nCriteria for Exclusion During Follow-Up\n\nParticipants will be excluded from the study during the follow-up period if they meet any of the following conditions:\n\n* Voluntarily choose to withdraw from the study.\n* Fail to complete at least two-thirds of the follow-up period for any reason.\n* Undergo bariatric surgery during the study.\n* Exhibit non-adherence to prescribed medications.\n* Have a general health condition that, according to their own statement, is unsuitable for continuing the study.","30 Years","65 Years",{"count":5,"type":21},[50],"This study aims to evaluate the effect of a preventive diabetic foot care program on the knowledge, behavior, self-management, and glycemic control levels of type 2 diabetic patients at risk of diabetic foot. The development of a Preventive Diabetic Foot Care Program (DiaFOOTCare) for patients with type 2 diabetes at risk of diabetic foot is expected to make a significant contribution to preventing diabetic foot formation. The DiaFOOTCare program consists of two stages. In the first phase, a comprehensive, multi-component, and evidence-based preventive diabetic foot care program will be designed specifically for type 2 diabetic patients at risk of diabetic foot. The internal validity of the program will be tested through expert evaluations by specialists in diabetic foot care, assessments using readability formulas, and pre-application testing with patients identified as being at risk of diabetic foot. As part of the final implementation of the first phase, all interventions included in the DiaFOOTCare protocol will be administered to four patients with diabetic foot risk over a three-week period. Following this, the DiaFOOTCare protocol will be evaluated based on the feedback provided by these four pre-application participants. In the second phase, a randomized controlled trial (RCT) with a single-blinded and active control group design will be conducted at the Akdeniz University Hospital Endocrinology and Metabolic Diseases Outpatient Clinic. A group of patients with type 2 diabetes and diabetic foot risk will be identified, and pre-tests will be administered. The patients will then be randomly assigned to the intervention group (n=39) and the control group (n=39). The effectiveness of the DiaFOOTCare program will be assessed through post-tests.",[25,105],"Type 2 Diabetes Mellitus With Complication",[107,108,109,110,111],"Nursing","Type 2 Diabetes Mellitus","Diabetic Foot","Preventive Diabetic Foot Care","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-06-09",{"date":115,"type":30},"2026-06-10",{"date":59,"type":21},{"date":118,"type":21},"2026-08-01",{"name":120,"class":121},"Akdeniz University","OTHER",{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":17,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":48,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":143},"100423253","exercise-enhances-wound-healing-in-patients-with-diabetic-foot-ulcers-100423253","NCT04791449","Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers","Inclusion Criteria:\n\n* diagnosis of type 2 diabetes\n* 20 - 80 years of age\n* Ankle-Brachial Index (ABI) \\> 0.6 or Toe Pressure (TcPO2) \\> 40 mmHg\n* recent (within 12 weeks) blood glucose value between 100 - 350 mg\u002FdL\n* recent (within 12 weeks) HbA1c value \\\u003C 14 %,\n* DFU of WIfI Grade 2 or less\n* fluency in reading and speaking English or Spanish.\n\nExclusion Criteria:\n\n* inability to provide own consent\n* inability to obtain permission to participate from a medical professional\n* lack of consistent mode of transportation to UNMH\n* infection to any part of the body\n* patients that has had a transplant and\u002For is immunocompromised\n* prisoners.","20 Years","80 Years",{"count":131,"type":21},60,[50],"The overarching purpose of this study is to investigate the impact that exercise, as delivered through a medically supervised, outpatient cardiac rehabilitation program, has on the wound healing process in Type 2 diabetics having foot ulcers classified as being Wound, Ischemia, foot Infection (WIfI) stage 2 or lower. The criterion reference measure of diabetic foot ulcer wound healing is be the time required to reach the maturation phase of the wound healing cascade (wound closure without drainage).",[25],{"date":136,"type":30},"2026-06-11",{"date":138,"type":30},"2021-10-10",{"date":140,"type":21},"2035-05-31",{"name":142,"class":121},"University of New Mexico",1,{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":48,"phases":156,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":68},"100548380","clinical-utility-of-an-amniotic-membrane-allograft-for-diabetic-foot-ulcer-wound-management-100548380","NCT06420245","Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management","A Prospective, Post-market Randomized Controlled Trial (RCT) to Demonstrate Clinical Utility of an Amniotic Membrane Allograft in Diabetic Foot Ulcer (DFU) Wound Management","REBOUND","Inclusion Criteria\n\n1. Ambulatory patients ≥ 50 and ≤ 85 years of age;\n2. Willing and able to provide informed consent;\n3. Willing and able to comply with study requirements;\n4. Presence of Wagner 1 and superficial Wagner 2 DFU extending at least through the dermis provided the DFU is located in the foot distal to the medial malleolus\n5. If multiple Wagner 1 and superficial Wagner 2 DFUs are present, the largest ulcer meeting DFU eligibility criteria will be selected as the index DFU in the study;\n6. Index ulcer is able to be visualized and accurately measured with eKare Insights;\n7. Non-study ulcers must be \\> 2 cm (.79 in.) from the index ulcer;\n8. Index DFU identified ≥ 4 weeks prior to study screening and \\\u003C 52 weeks from the date of informed consent;\n9. Index DFU area \\> 1.0 cm2 (0.39 in.) and \\\u003C 25 cm2 (9.84 in.) at screening and at Wound Management Period Visit #1;\n10. Index DFU offloaded according to SOC for entire run-in period, prior to randomization;\n11. Potential participant is under the care of a clinician for diabetic management and other medical conditions (the site PI may assist\u002Fdirect the patient in the pre-screening period to obtain a PCP).\n12. Index foot has adequate circulation defined as meeting one (1) of the following within 30 days of screening:\n\nA. ABI ≥ 0.7 and ≤ 1.3 AND TBI \\> 0.7; B. Dorsum transcutaneous oxygen tension measurement (TcPO2) ≥ 40 mmHg; C. Arterial duplex with biphasic flow in BOTH the DP and PT arteries verified by PI and documented.\n\nExclusion Criteria\n\n1. Index foot ulcer documented to be caused by a medical condition other than diabetes;\n2. Potential subject has five (5) or more DFUs and\u002For VLUs in the target limb;\n3. DFU is secondary to Charcot neuroarthropathy;\n4. Treatment with an antibiotic impregnated primary dressing ≤ 4 weeks prior to study screening;\n5. Index ulcer is potentially or confirmed by biopsy to be cancerous;\n6. Index ulcer site has undergone radiation therapy;\n7. Venous leg ulcers in diabetic patients;\n8. Active infection proximal to or at site of index ulcer;\n9. Index foot ulcer reduced in area by ≥ 20% at the end of the 4-week run-in period;\n10. Presence of active osteomyelitis or bone infection as verified by x-ray \u002FMRI within 30 days of visit #1 of the run-in period;\n11. Raynaud's disease;\n12. Unreconstructible arterial ischemia which may lead to nonhealing;\n13. Treatment with immunosuppressants, including systemic corticosteroids for ≥ 2 weeks within 30 days prior to study screening, or are anticipated during study participation;\n14. Any active cancer undergoing treatment ≤ 30 days prior to wound management visit #1 of the run-in period, or is anticipated during study participation;\n15. Treatment with chemotherapy within 30 days of the first study wound management visit of the run-in period, or is anticipated during study participation;\n16. Diabetics with poor metabolic control, defined as HbA1c ≥ 12.0%, within 30 days of visit #1 of the run-in period;\n17. Participation in an investigational device, biologic, or drug study currently or within 30 days of study wound management visit #1 of the run-in period;\n18. Prior use of any advanced skin substitute product on the index ulcer within 60 days of visit #1 of the run-in period;\n19. Index ulcer was continued to be treated after visit #1 of the run-in period and\u002For anticipate treatment during study participation with any of the following prohibited therapies:\n\n    1. Biomedical or topical growth factor;\n    2. Topical steroids applied to the index ulcer surface;\n    3. On medications that are considered immune system modulators that could affect graft incorporation;\n    4. Scarlet red dressing;\n    5. Dakin's solution;\n    6. Mafenide acetate;\n    7. Tincoban;\n    8. Zinc sulfate;\n    9. Povidone-iodine solution;\n    10. Polymyxin\u002Fnystatin;\n    11. Chlorhexidine;\n20. Patient is taking a cyclooxygenase-2 inhibitor (COX-2 inhibitor); such as, celecoxib (Celebrex, Consensi, Elyxyb), valdecoxib (Bextra), amlodipine (Consensi);\n21. Patient has serum creatinine \\> 2.5 mg\u002FdL within 30 days of study wound management visit #1 of the run-in period;\n22. Autoimmune connective tissue disease;\n23. End stage renal disease (ESRD);\n24. Presence of any condition which would seriously compromise the subject's ability to complete this study;\n25. Known history of poor adherence to medical therapy and\u002For clinic appointments;\n26. Pregnant, or planning to become pregnant during the study;\n27. Life expectancy \\\u003C 1 year.","50 Years","85 Years",{"count":155,"type":21},240,[50],"The goal of this clinical trial is to learn if use of Orion™, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers. The study aims to determine the incidence of complete wound closure at the end of 12 weeks of treatment. Researchers will compare the outcomes between a group of people treated with standard wound care and another group treated with standard wound care in addition to the amniotic membrane allograft to see if the amniotic membrane allograft improves wound healing.\n\nDuring the study, participants will visit their doctor weekly over a 12 week period, which is standard for diabetic foot ulcer treatment procedures, and fill out a questionnaire measuring quality of life.",[25],[160,161,162],"amniotic membrane allograft","diabetic foot ulcer","DFU","2026-06-04",{"date":165,"type":30},"2026-06-05",{"date":167,"type":30},"2025-12-30",{"date":169,"type":21},"2027-07",{"name":171,"class":37},"Legacy Medical Consultants",{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":48,"phases":182,"briefSummary":183,"conditions":184,"keywords":187,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":143},"100512300","wiredup-wearable-insoles-for-recurrent-diabetic-ulcer-prevention-100512300","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",{"count":181,"type":21},400,[50],"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.",[185,186,109,25],"Diabetes","Peripheral Neuropathy",[188,189,190],"Remote Patient Monitoring","Sensor-based Monitoring","Sensory Insoles",{"date":192,"type":30},"2026-06-08",{"date":194,"type":30},"2026-04-22",{"date":196,"type":21},"2029-04-01",{"name":198,"class":121},"Johns Hopkins University",{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":129,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":143},"100562059","mirragen-diabetic-foot-ulcer-study-100562059","NCT06598241","Mirragen Diabetic Foot Ulcer Study","A Pilot, Post-market, Non-interventional, Prospective, Observational Study of Standard of Care of the Commercially Available Borate-base Bioactive Glass Fiber Matrix (BBGFM) in Treatment of Outpatient Diabetic Foot Ulcer With Chronic Osteomyelitis.","Inclusion Criteria:\n\n1. The subject has signed the informed consent form\n2. Subject is male or female aged between ≥ 18 or ≤ 80\n3. Subject scheduled to receive borate-based bioactive glass fiber matrix in treatment of index diabetic foot ulcer\n4. Index ulcer has not received an application of BBFGM previously\n5. Subjects with insurance coverage for BBGFM\n6. Subject has documented Type 1 or Type 2 diabetes with an HbA1c less than or equal to 12.0% within 90 days of enrollment.\n7. The subject is under the care of Physician for the management of Diabetes Mellitus\n8. Subject must have a wound present anatomically on the foot as defined by beginning below the malleoli of the ankle, dorsal surface, plantar surface, inter digital, heel, lateral or medial surface of the foot\n9. Subject index ulcers must be ≥ 0.5 cm2 and ≤ 8.0 cm2\n10. Index ulcer has been present for greater than 4 weeks prior to enrollment and less than 2-years, as of the date the subject receives the BBGFM\n11. The BBGFM will be applied in an outpatient setting\n12. Subject has an ulcer with a Wagner Grade 2 or 3 classification Wagner Grade 2: Deep ulcer extended to ligament, tendon, joint capsule, bone, or deep fascia without abscess or osteomyelitis Wagner Grade 3: Ulcers extend to the deep tissue and have either associated soft tissue abscess or osteomyelitis If Wagner Grade 3 Ulcer with chronic osteomyelitis, that can be debrided in an outpatient setting, in the opinion of the investigator\n\n    1. Exposed or palpable bone in the reference ulcer, that can be surgically excised in an outpatient clinic setting, using local anesthetic, at the screening or randomization visit\n    2. Less than a 1cm margin of peri-ulcer tissue of the reference ulcer, requiring surgical debridement, at the screening and randomization visit\n\n    Wagner Grade 3 subjects must have osteomyelitis diagnosed by:\n\n    X-ray: suggestive or positive for changes consistent with chronic osteomyelitis or Positive probe to bone (PTB) test or Strong clinical suspicion, in the opinion of the Investigator, in the presence of osteomyelitis in the index wound\n13. Subject does not require a surgical debridement in the operating room\n14. Subjects without active cellulitis at the index ulcer\n15. Subject or responsible caregiver is willing to comply with the dressing treatment and study visits\n16. Subject is willing to utilize the offloading device to offload wound\n17. If female, subjects must have been practicing adequate contraception (abstinence, barrier method, hormonal, or IUD). Must agree to using an accepted and effective form of birth control during the study.\n18. Subject has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following tests within 60 days (about 2 months) prior to enrollment:\n\nA.Ankle-Brachial Index (ABI) of study leg(s) of ≥0.7 to ≤1.3 in conjunction with doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg Or B.Toe brachial Index (TBI) of ≥ 0.50 OR C.Great Toe Pressure 50mmHg OR D.Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) of ≥40mmHg on the dorsum of the affected foot OR E.Palpable pulses\n\nExclusion Criteria:\n\n1. Subject is unwilling to sign informed consent\n2. Subjects who cannot obtain insurance coverage for BBFGM\n3. The BBFGM cannot be applied in an outpatient setting\n4. Index ulcer has previously received an application of BBFGM\n5. Subject has a major contralateral amputation of lower extremity, specifically transmetatarsal amputation or more proximal amputation\n6. Subject index ulcer has a known history of borate-base bioactive glass fiber matrix application\n7. Subject is pregnant or breast-feeding.\n8. Subject index ulcer associated with carcinoma.\n9. Subject has active Charcot Neuroarthropathy\n10. Subject requires extensive soft tissue and bone debridement in the operating room\n11. Subject has a life expectancy of less than six months as assessed by the investigator.\n12. Subject not in reasonable metabolic control in the judgment of the investigator\n13. Subject with a known history of poor compliance with medical treatments\n14. Subject currently undergoing cancer treatment\n15. Subject has been on oral steroid use of \\\u003C7.5 mg daily for greater than seven consecutive days in 30 days before screening\n16. Subject is taking parenteral corticosteroids or any cytotoxic agents for seven consecutive days in the period of 30 days before screening\n17. The subject has malignancy or a history of cancer, other than non-melanoma skin cancer, in five years before screening\n18. Subject has been diagnosed or had medical history with at least one of the following diseases: cancer, lupus, vasculitis, sickle cell, fibromyalgia, acquired immunodeficiency syndrome (AIDS) or HIV, uncontrolled rheumatoid arthritis, stage renal disease.\n19. Subject currently receiving radiation therapy or chemotherapy.\n20. Patient currently on dialysis or planning to start dialysis.\n21. Presence of any condition that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator\n22. Subject is unable to sustain off-loading as defined by the protocol\n23. Subject index ulcer that cannot be offload by an offloading device\n24. Subject index ulcer with acute osteomyelitis, as per no bony changes on x-ray and\u002For presence of acute cellulitis at the index ulcer\n25. Subject is anticipated to use Negative Pressure Wound Therapy (NPWT) on the index ulcer during the study\n26. Subjects who are permanently non-ambulatory (i.e. wheelchair bound)\n27. The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner)\n28. Subject has an allergy to primary or secondary dressing materials used in this trial\n29. In the opinion of the Investigator the subject is not appropriate for inclusion in the trial, e.g., undergoing surgical treatments listed in the protocol or subject currently has sepsis, i.e., life threatening organ dysfunction caused by a dysregulated host response to infection",{"count":207,"type":21},20,"This study is being done to collect data from treatment of patients who have diabetes with non-healing foot wounds and are being treated with a resorbable and biocompatible borate-based bioactive glass fiber matrix. A borate-based bioactive glass fiber matrix is used to cover the ulcer for wound management. The primary objective of this study is to evaluate the safety and efficacy of the borate-based bioactive glass fiber matrix in the treatment of diabetic foot ulcers in a real-world setting. The secondary objective is to evaluate the clinical and financial benefits in terms of quality of healing, pain, and treatment cost.",[25,210],"Osteomyelitis Chronic",[212],"Glass fiber matrix","2026-06-02",{"date":163,"type":30},{"date":216,"type":30},"2024-09-20",{"date":218,"type":21},"2026-12",{"name":220,"class":121},"The University of Texas Health Science Center at San Antonio",{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":228,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":143},"100639478","theravex-tissue-care-spray-plus-for-the-management-of-cutaneous-wounds-burns-and-chronic-ulcers-100639478","NCT07617961","THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers","Pilot Clinical Evaluation of THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers","Inclusion Criteria\n\nAdult patients aged 18 years or older. Patients presenting with cutaneous wounds: burns, traumatic wounds, pressure ulcers, diabetic ulcers, or chronic cutaneous lesions.\n\nPatients considered clinically suitable for topical treatment with THERAVEX Tissue Care Spray Plus.\n\nExclusion Criteria Known allergy or hypersensitivity to any component of THERAVEX Tissue Care Spray Plus.\n\nPresence of severe uncontrolled systemic infection requiring immediate surgical intervention.\n\nParticipation in another interventional clinical study that could interfere with wound healing assessment.",true,{"count":230,"type":21},26,"Pilot observational clinical evaluation assessing the safety and potential effectiveness of THERAVEX Tissue Care Spray Plus as an adjunctive topical therapy for the management of cutaneous wounds, burns, traumatic lesions, pressure ulcers, diabetic ulcers, and chronic ulcers in 26 patients. The study evaluated wound healing progression, epithelialization, tissue hydration, inflammatory response, tolerance, and overall clinical evolution in patients receiving standard wound care combined with topical application of THERAVEX Tissue Care Spray Plus. Preliminary observations demonstrated favorable tissue response, progressive epithelial regeneration, reduction of inflammatory signs, and absence of treatment-related adverse events.",[82,233,234,235,25],"Burns","Pressure Ulcer","Traumatic Wounds","2026-06-01",{"date":163,"type":30},{"date":239,"type":30},"2025-10-02",{"date":241,"type":21},"2027-05-21",{"name":243,"class":37},"Biointelligent Technology Systems SL",{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":48,"phases":254,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":269,"locationsCount":143},"100599588","phase-4-randomized-evaluation-of-nonhealing-diabetic-foot-ulcers-with-exclusive-wound-therapy-100599588","NCT07086443","Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating Placental Derived Allografts and Standard of Care in the Treatment of Nonhealing Diabetic Foot Ulcers Using Matched Controls","RENEW","Inclusion Criteria:\n\n* The potential subject must be at least 18 years of age or older.\n* The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.\n* At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the imaging device length times width.\n* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.\n* The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.\n* The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.\n* The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n  1. ABI between 0.7 and ≤ 1.3;\n  2. TBI ≥ 0.6;\n  3. TCOM ≥ 40 mmHg;\n  4. PVR: biphasic. 8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n* The potential subject must have a target ulcer located on the 50% below the malleolus and not on the dorsal toes.\n* The ulcer must be offloaded for at least 14 days prior to enrollment.\n* The potential subject must consent to using the prescribed offloading method for the duration of the study.\n* The potential subject must agree to attend the weekly study visits required by the protocol.\n* The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n* The potential subject is known to have a life expectancy of \\\u003C 6 months.\n* The potential subject's target ulcer is not secondary to diabetes.\n* The target ulcer is infected or there is cellulitis in the surrounding skin.\n* The target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the target ulcer.\n* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n* The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n* The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n* The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.\n* The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.\n* The potential subject has end stage renal disease requiring dialysis.\n* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n* The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n* The potential subject has a malnutrition.\n* The potential subject has a known allergy or sensitivity to PBS, IPA, processing solutions, reagents, or latex.",{"count":253,"type":21},350,[255],"PHASE4","The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.",[25,162,258,259,260,261,262],"Diabetic Foot Ulcer (DFU)","Foot Ulcer Due to Type 1 Diabetes Mellitus","Foot Ulcer Due to Type 2 Diabetes Mellitus","Ulcer","Ulcer Foot","2026-05-18",{"date":265,"type":30},"2026-05-19",{"date":267,"type":30},"2025-07-11",{"date":169,"type":21},{"name":270,"class":37},"Sequence LifeScience, Inc.",{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":48,"phases":281,"briefSummary":282,"conditions":283,"keywords":284,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":297},"100571553","diabetes-related-foot-ulcers-with-negative-pressure-wound-therapy-100571553","NCT06721754","Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy","Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy: A Randomized Controlled Trial","DIANE","Inclusion Criteria:\n\n* Male and non-pregnant female above 18 years with a diabetic foot ulcer in need of surgical debridement or forefoot amputation\n\nExclusion Criteria:\n\n* Previous leg amputation due to diabetes\n* Unable to ambulate on feet\n* Unlikely to adhere to treatment and\u002For follow-up\n* Unable to complete questionnaire\n* Active or ongoing cancer treatment\n* In need of amputation at a higher level than metatarsal or more than two metatarsals",{"count":280,"type":21},50,[50],"The goal of this study is to learn if the clinical effects of Negative Pressure Wound Therapy (NPWT) is better, worse or the same as standard wound care for patients with diabetic foot ulcers (DFUs).\n\nThe main questions it aims to answer are:\n\n* Will there be a difference in the number of major amputations between the groups during the first year?\n* Will one of the treatments require more surgeries and longer hospital stays?\n\nAll participants will:\n\n* be treated with NPWT or standard wound care for their diabetic foot ulcer after surgery\n* be followed closely at the out-patient clinic for one year after treatment",[25],[25,285,111,286,287],"Negative Pressure Wound Treatment","Standard Wound Treatment","Amputation","2026-04-28",{"date":290,"type":30},"2026-05-04",{"date":292,"type":30},"2025-01-02",{"date":294,"type":21},"2028-12-31",{"name":296,"class":121},"University Hospital, Akershus",2,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":305,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":48,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":143},"100627127","transverse-tibial-bone-transport-ttt-in-the-management-of-chronic-diabetic-lower-extremity-wounds-100627127","NCT07444593","Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds","SMILE - TTT: Surgical MIcrovascularization of Lower Extremities for Diabetic Foot Ulcers - Transverse Tibial Transport Study","Inclusion Criteria:\n\n* Adults (\\>=22 years).\n* Chronic diabetic foot ulcer wound persisting \\>=12 weeks and less than 104 weeks refractory to standard wound care.\n* Wound location within distal 1\u002F3 tibia and below including foot.\n* Wound stages: WiFi \\>= 3\n* At least one patent lower extremity tibial vessel (after revascularization if needed).\n* Able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Active systemic infection (positive blood cultures)\n* Severe sepsis (2 out of 4 SIRS criteria with impact on organ dysfunction)\n* Subacute lower extremity wound \\\u003C12 weeks with or without standard wound cares\n* Internal hardware within 10cm of possible TTT placement\n* Most proximal aspect of wound within 10cm of most distal pin of possible TTT placement\n* End Stage Renal Disease requiring dialysis\n* Renal function values\n\n  * eGFR: \\\u003C15ml\u002Fmin and\n  * Creatinine: \\>6mg\u002FdL and\n  * BUN: \\>50 mg\u002FdL\n* Wounds less than 1 cm3 or greater than 30 cm3\n* Corticosteroids \\>10mg prednisone equivalent daily for \\>2 weeks\n* Patients with osteomyelitis in the ipsilateral tibia at planned corticotomy site\n* Cognitive or social limitations precluding consent or follow-up\n* Current participation in another investigational study (drug or device)\n* Immunocompromised (WBC \\\u003C4) or undergoing active chemotherapy\n* Hemoglobin A1c \\>12\n* BMI \\\u003C18.5 kg\u002Fm2\n* Pregnant, lactating, or planning to become pregnant\n* Life expectancy less than 12 months\n* Severe hepatic impairment defined by patient on a transplant list, MELD \\> 20, Child's class C.\n* A history of conditions that may impair wound healing in the opinion of the Investigator, for example, autoimmune disorders, renal failure patients on dialysis, or medications that impair the healing process.","22 Years",{"count":20,"type":21},[50],"The purpose of this study is to evaluate the safety and clinical performance of transverse tibial bone transport in patients with chronic ischemic and diabetic lower extremity ulcers. This study will assess wound healing outcomes and limb preservation in a population with limited therapeutic alternatives.",[25,310],"Chronic Ulcers of the Lower Limb",[312,162,313,314,315],"Transverse Bone Transport","TTT","Biodynamik","XT3",{"date":317,"type":30},"2026-04-27",{"date":319,"type":21},"2026-05-01",{"date":321,"type":21},"2027-02-28",{"name":323,"class":37},"Biodynamik, Inc",{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":17,"minAge":128,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":48,"phases":333,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":342,"locationsCount":344},"100545523","phase-2-bb-101-for-the-treatment-of-diabetic-lower-leg-and-foot-ulcers-100545523","NCT06383013","BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers","Phase II Study to Evaluate the Efficacy and Safety of Topical BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers","Inclusion Criteria:\n\n* Male or female, at least 20 years of age (inclusive) at the date of Screening\n* Subject or legally authorized representative who is able to understand the nature of this study and accepts to enter the study by signing written informed consent\n* Subject agrees to comply with ulcer care regimen for the duration of the study and is willing to return for all mandatory visits as defined in the protocol\n* Subject with Type 1 or Type 2 diabetes mellitus (criteria for the diagnosis of diabetes mellitus per American Diabetes Association) and is under the care of a physician for the management of diabetes mellitus\n* Subject with glycosylated hemoglobin (HbA1c) ≤ 12%\n* Subject with at least one diabetic foot ulcer meets the following criteria at Screening\n\nVisit:\n\ni. Located below knees; ii. Not healing for ≥ 4 weeks prior to Screening Visit despite appropriate care; iii. Ulcer size of ≥ 0.5 cm2 to ≤ 10 cm2 measured by the electronic measuring device following sharp debridement (if necessary) at Screening Visit and reconfirmed at Randomization Visit; iv. The largest ulcer will be selected as target ulcer. If ≥ 2 ulcers have the largest size, the one with the worst grade by Wagner Classification will be selected. If ≥ 2 ulcers have the largest size and grade, the one with longest duration will be selected; v. The target ulcer is classified as Grade 1 to Grade 2 according to Wagner Classification System for diabetic foot ulcer; vi. The target ulcer should be without clinical signs and symptoms of infection\n\n* Subject with adequate circulation to the affected lower limb, as demonstrated by at least one of the following criteria: i. Dorsum transcutaneous oximetry (TcPO2) ≥ 30 mmHg ii. Ankle brachial pressure index (ABPI) ≥ 0.7 iii. Absolute toe blood pressure \\> 30 mmHg iv. Doppler ultrasonography showed \\\u003C 75% stenosis in the lower extremity arteries\n* Subject with adequate hepatic (ALT and AST ≤ 2 × ULN) and renal function (Serum creatinine ≤ 3 mg\u002FdL)\n* Subject with adequate hematology function:\n\n  i. Absolute neutrophil count (ANC) ≥ 1,500 cells\u002FμL ii. Total white blood cell (WBC) ≥ 3,000 cells\u002FμL iii. Platelets ≥ 100,000 counts\u002FμL iv. Hemoglobin ≥ 10 g\u002FdL for male, ≥ 9 g\u002FdL for female\n* Female subjects show negative serum pregnancy test results within 28 days prior to the first study treatment.\n* All male subjects and female subjects with child-bearing potential (between puberty and 2 years after menopause) should use at least any one of the appropriate contraception methods during dosing and for at least 4 weeks after stopping study treatment.\n\nExclusion Criteria:\n\n* Clinical signs and symptoms of infection of target ulcer assessed by clinical evaluation.\n\nThe presence of infection is defined by ≥ 2 of the items presented as:\n\n* Local swelling or induration\n* Erythema \\> 0.5 cm around wound\n* Local tenderness or pain\n* Local increased warmth\n* Purulent discharge\n\n  * Subject with cellulitis or gangrene on the lower leg or foot with the target ulcer\n  * Subject with active osteomyelitis, which requires systemic antibiotics. Systemic antibiotics must be complete or discontinued 1 week prior to Screening Visit.\n  * With target ulcer size decreased or increased by at least 30% after receiving 2 weeks of standard-of-care for diabetic foot ulcer before Randomization visit\n  * Subject with another open ulcer \\\u003C 2 cm away from target ulcer, on the same lower leg or foot\n  * Subject with target ulcer caused primarily by etiologies not related to diabetes\n  * Subject with target ulcers related to an incompletely healed amputation wound\n  * Subject with any structural deformity of the lower leg or foot under study that would prevent off-loading of the target ulcer; subject with conditions which may interfere the off-loading effect may be excluded by the Investigators' judgment\n  * Subject is scheduled to (or has received within 4 weeks prior to Screen Visit) receive any of the following medications or treatments:\n* Platelet-derived product (e.g., becaplermin) or other growth factors on the target ulcer\n* Systemic corticosteroids (other than for inhalation), immunosuppressive agents, radiation therapy, or chemotherapeutic agents\n* Participation in a clinical trial of an investigational drug or device\n\n  * Previous use of autologous graft or allogeneic graft, or dermal substitute or living skin equivalent (e.g., Dermagraft® or Apligraf® ) on the target ulcer or hyperbaric oxygen therapy within 2 weeks prior to Screening Visit\n  * Use of any topical antimicrobials or enzymatic debridement treatment to treat the target ulcer within 7 days prior to Screening Visit\n  * Subject with history of cancer or current cancer, with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to administration of any study agent\n  * Vasculitis, connective tissue diseases, or any medical conditions known to impair ulcer healing, other than diabetes\n  * Subject diagnosed with sickle cell disease\n  * Subject with clinically significant electrocardiogram (ECG) abnormality, as determined by the Investigator\n  * Poor nutritional status (serum albumin \\\u003C 2.5 g\u002FdL)\n  * C-reactive protein (CRP) \\> 50 mg\u002FdL\n  * Subject had a history of drug abuse or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria.\n  * Patient with positive result of Human immunodeficiency virus (HIV)\n  * Female subject in lactation during the study period\n  * Subject with underlying medical, mental or psychological conditions that would impair the treatment compliance, or in the opinion of the Investigator would not permit to participate in the study",{"count":332,"type":21},96,[334],"PHASE2","This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer.",[25],"2026-04-20",{"date":194,"type":30},{"date":340,"type":30},"2024-05-01",{"date":294,"type":21},{"name":343,"class":37},"Blue Blood Biotech Corp.",5,{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":48,"phases":355,"briefSummary":356,"conditions":357,"keywords":360,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":143},"100623364","subcutaneous-dexpanthenol-administration-and-wound-epithelialization-100623364","NCT07395674","Subcutaneous Dexpanthenol Administration and Wound Epithelialization","Evaluation of the Effect of Subcutaneous Dexpanthenol Administration on Wound Epithelialization: A Pilot Randomized Controlled Study","DEXPAN-WOUND","Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Presence of a chronic wound, including diabetic foot ulcer, venous leg ulcer, or arterial ulcer.\n* Target wound size between 1 and 20 cm² at baseline.\n* Non-infected wound, defined by the absence of purulent discharge, foul odor, spreading erythema, cellulitis, or systemic signs of infection.\n* Clinically stable patients without the need for systemic antibiotic therapy.\n* Ability to understand the study procedures and provide written informed consent.\n* Willingness and ability to comply with study visits and treatment schedule.\n\nExclusion Criteria:\n\n* Clinical signs of wound infection or requirement for systemic antibiotic treatment.\n* Critical limb ischemia, defined as ankle-brachial index \\\u003C0.5, rest pain, gangrene, or extensive tissue necrosis.\n* Wounds exposing bone, tendon, or joint structures, or suspected osteomyelitis.\n* Wound size smaller than 1 cm² or larger than 20 cm².\n* Malignant, autoimmune, vasculitic, or specific dermatologic conditions causing the wound.\n* Known hypersensitivity or allergy to dexpanthenol or any component of the study treatments.\n* Pregnancy or breastfeeding.\n* Cognitive impairment or inability to provide informed consent.\n* Participation in another interventional clinical trial that could interfere with the outcomes of this study.\n* Any medical condition that, in the investigator's judgment, could compromise participant safety or study integrity.",{"count":354,"type":21},40,[50],"Chronic wounds are wounds that do not heal properly over time and can significantly reduce quality of life. Common types include diabetic foot ulcers, venous leg ulcers, and arterial ulcers. Improving wound healing and speeding up skin regeneration (epithelialization) are important goals in the care of these patients.\n\nDexpanthenol is a vitamin B5 derivative that supports skin repair and tissue regeneration. It is widely used in topical treatments, and injectable forms are approved for clinical use. However, the effects of subcutaneous (under the skin) dexpanthenol injections on chronic wound healing have not been sufficiently studied in clinical settings.\n\nThe purpose of this study is to evaluate whether adding subcutaneous dexpanthenol injections to standard wound care improves wound healing compared with standard wound care alone. Adult patients with non-infected chronic wounds will be randomly assigned to one of two groups. One group will receive standard wound care only, while the other group will receive standard wound care plus subcutaneous dexpanthenol injections around the wound area.\n\nWound healing will be assessed by measuring changes in wound size and the degree of skin epithelialization over time using standardized and objective methods. Safety will be monitored by recording local reactions at the injection site and any other adverse events during the study.\n\nThe results of this study may provide preliminary clinical evidence on the effectiveness and safety of subcutaneous dexpanthenol as an additional treatment option for chronic wound management.",[82,25,358,359],"Venous Leg Ulcers","Arterial Ulcer",[361,82,362,363,25,364,359,111],"Dexpanthenol","Wound Healing","Epithelialization","Venous Leg Ulcer","2026-04-16",{"date":367,"type":30},"2026-04-21",{"date":369,"type":21},"2026-08-02",{"date":371,"type":21},"2028-12-02",{"name":373,"class":121},"Dilara CANBAY OZDEMIR",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":48,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":297},"100555669","study-assessing-complete-wound-healing-by-comparing-surgenex-pellograft-in-treating-dfu-and-sanograft-in-treating-vlu-to-soc-100555669","NCT06515093","Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC","A Randomized Post-Market Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating Diabetic Foot Ulcers (DFU) and SanoGraft® in Treating Venous Leg Ulcers (VLU) to SOC Treatment","Inclusion Criteria:\n\n1. Subject is at least 18 years of age\n2. Diabetic Foot Ulcer Only - Subject has diagnosed Type 1 or Type 2 diabetes\n3. Subject's wound is located on foot or ankle (DFU) or leg (VLU)\n4. Subject has diabetic foot ulcer \\> 1.0 cm2 and ≤ 25 cm2 OR venous leg ulcer \\> 1.0 cm2 and ≤ 50 cm2\n5. Subject has adequate circulation to affected extremity with TcPO2 results of ≥ 40 mm Hg on the dorsum of the affected foot or ABI results ≥ 0.7 and≤ 1.2 or Great Toe Pressure ≥ 50 mmHg\n6. Subject is willing and able to comply with all protocol requirements\n7. Subject is willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)\n\nExclusion Criteria:\n\n1. Subject is pregnant\n2. Subject with diagnosed diabetes has HbA1C \\> 12 within 3 months Prior to randomization\n3. Subject has \\> 30% reduction in wound size after 2-week run-in period\n4. Subject has active infection, undrained abscess, or critical colonization of the wound with bacteria\n5. Subject has osteomyelitis or joint capsule on investigator's exam or radiographic evidence or bone culture, histology, x-ray changes or MRI\n6. Subject is on parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during 30 days before screening. Chronic oral steroid use is not excluded if dose \\\u003C 10 mg per day of prednisone\n7. Subject is currently undergoing cancer treatment\n8. Subject has used biologic skin substitutes within 14 days of enrollment\n9. Subject has an allergy to suture material\n10. Subject has life expectancy less than six-months as assessed by the investigator\n11. Subject is participating in another clinical research study prior to this study completion",{"count":382,"type":21},180,[50],"The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to compare Sanograft to standard of care in treating venous leg ulcers. The study will demonstrate wound healing outcomes with comparators including time to wound epithelialization, decrease in wound size, and total number of study product applications towards healing outcome. This information is important to the Centers for Medicare and Medicaid Services (CMS) and other payors in determining coverage policy and reimbursement for this product category.",[25,364],"2026-04-01",{"date":388,"type":30},"2026-04-07",{"date":390,"type":30},"2024-06-23",{"date":392,"type":21},"2027-09-08",{"name":394,"class":37},"Surgenex",{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":48,"phases":404,"briefSummary":405,"conditions":406,"keywords":408,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":418,"leadSponsor":420,"locationsCount":4},"100628745","evaluating-the-efficacy-of-pulsating-electromagnetic-field-therapy-by-crad-ulcer-x-01-for-diabetic-foot-ulcers-100628745","NCT07465640","Evaluating the Efficacy of Pulsating Electromagnetic Field Therapy by CRAD ULCER X-01 for Diabetic Foot Ulcers","Evaluating the Efficacy of Pulsating Electromagnetic Field (PEMF) Therapy for Diabetic Foot Ulcers Using the CRAD ULCER X-01 Device: A Randomised Parallel-Group Pilot Study","Inclusion Criteria:\n\n* Provision of written consent by subjects.\n* Subject of either sex.\n* At least 18 years of age.\n* Known diabetes mellitus.\n* Diagnosed with chronic DFU Grade I-III and Stage A according to the University of Texas Classification as recommended in the Malaysian Clinical Practice Guidelines for the Management of Diabetic Foot (2nd Edition).\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide written consent.\n* Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.\n* Other medical conditions which, in the investigator's judgement, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.\n* Participation in another clinical trial and\u002For recipient of investigational therapy within 4 weeks prior to screening visit.\n* Patients who have metal implants in any part of the body.\n* Patients with a pacemaker.\n* History of malignancies.\n* Presence of chronic kidney disease co-morbidity.\n* Presence of severe peripheral artery disease, assessed when the ankle-brachial index (ABI) is \\\u003C0.40.",{"count":403,"type":21},32,[50],"Background: Diabetic foot ulcer (DFU) is a frequent complication of chronic, uncontrolled diabetes mellitus (DM). Treatment with antibiotics, daily dressing, wound debridement, and wound off-loading is often prescribed. However, many DFU patients still progress into severe outcomes, including non-healing of wounds, infections, necrosis, and osteomyelitis. Prior research has shown that the application of pulsating electromagnetic field (PEMF) could accelerate wound healing, including in those afflicted with DFUs. Therefore, this study aimed to evaluate the efficacy of a locally developed CRAD ULCER X-01 device that uses the principles of PEMF in promoting DFU healing. Methods: A total of 32 patients with chronic, non-healing DFUs will be recruited from the Orthopaedic Clinic of Hospital Angkatan Tentera Tuanku Mizan and divided into control (C) (n=8) and treatment (T) (n=24) groups. All patients will receive a standard daily dressing. The PEMF will be supplemented for 1 hour\u002Fday, 2 hours\u002Fday, and 3 hours\u002Fday for T1, T2, and T3 subgroups, respectively (n=8 per group); whereas the C group will be controlled for placebo effect (device in-place but switched off). The therapy duration will be until the wound is closed or for a maximum period of three months. All patients will undergo wound assessment, wound edge tissue histology by haematoxylin and eosin (H\\&E) staining, and immunohistology (for vascular endothelial growth factor \\[VEGF\\] and fibroblast growth factor 2 \\[FGF-2\\] expression), as well as serum superoxide dismutase (SOD) and C-reactive protein (CRP) at preand post-treatment, along with glycated haemoglobin (HbA1c) measurement only at post-treatment to control for confounder (i.e., glucose control for the past three months). This study hypothesizes that PEMF therapy by CRAD ULCER X-01 device will accelerate DFU healing and improve tissue integrity, with minimal systemic effects assessed via oxidative stress and inflammatory markers. Conclusion: The results from this study will validate PEMF's effectiveness in promoting DFU healing and establish the potential use of locally developed CRAD ULCER X-01 devices as supplementary therapy to standard DFU care.",[25,407],"Diabetes Mellitus (DM)",[409,410,411,412,161,413],"pulsating electromagnetic field","wound healing","oxidative stress","inflammation","diabetes mellitus","2026-03-11",{"date":416,"type":30},"2026-03-13",{"date":416,"type":21},{"date":419,"type":21},"2027-04-01",{"name":421,"class":121},"National Defence University of Malaysia",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":48,"phases":430,"briefSummary":431,"conditions":432,"keywords":433,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":441,"locationsCount":442},"100595972","prospective-case-series-evaluating-the-efficacy-and-safety-of-neothelium-ft-for-diabetic-foot-ulcers-100595972","NCT07039396","Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers","Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Diabetic Foot Ulcers: A Prospective Case Series","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and\u002For insulin replacement therapy with a diabetic foot ulcer\n3. Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior to screening.\n4. Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit\n5. Subject is able and willing to follow the protocol requirements\n6. Subject had signed informed consent\n7. Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.\n8. Diabetic foot ulcer is being treated with TCC offloading therapy OR Fixed Ankle Walker if approved by Medical Monitor for 7 days prior to treatment visit 1\n9. Wound free of clinical infection (no purulent discharge, cellulitis, or osteomyelitis) post-debridement.\n10. Record of serum hemoglobin A1c within 90 days prior to the first treatment visit\n\nExclusion Criteria:\n\n1. Subject is unable to comply with protocol treatment\n2. Target ulcer is a Wagner 3 of acute osteomyelitis that has not been successfully treated with 6 weeks of IV antibiotics or is diagnosed as chronic refractory osteomyelitis.\n3. Wagner 3, 4, or 5 involving tendon, bone, or joint.\n4. Presence of systemic infection, sepsis, or osteomyelitis at screening.\n5. Multiple DFUs on the same foot with \\\u003C 2 cm separation from the target ulcer.\n6. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing.\n7. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.\n8. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n9. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.\n10. Concurrent participation in alternative clinical trial that involves investigational drug or HCT\u002FP interfering with wound treatment and\u002For healing.\n11. Subject is pregnant or breastfeeding\n12. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>2 weeks duration within 30 days prior to the first treatment visit; or anticipated use of the above during the course of the study\n13. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment\n14. Index ulcer suspicious of neoplasm in the opinion of the principal investigator",{"count":91,"type":21},[50],"This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers",[25],[82,434,57,58],"Cellular, Acellular, Matrix-like product (CAMP)","2026-03-10",{"date":437,"type":30},"2026-03-12",{"date":439,"type":30},"2025-08-26",{"date":236,"type":21},{"name":67,"class":37},3,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":17,"minAge":449,"maxAge":450,"enrollmentInfo":451,"targetDuration":4,"studyType":48,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":461,"locationsCount":143},"100625830","effect-of-monochromatic-infrared-energy-on-healing-of-diabetic-foot-ulcers-100625830","NCT07427732","Effect of Monochromatic Infrared Energy on Healing of Diabetic Foot Ulcers","Inclusion Criteria:\n\n* Diagnosis of Diabetes Mellitus: Participants must have a confirmed diagnosis of Type 1 or Type 2 diabetes.\n* Presence of a Diabetic Foot Ulcer (DFU): Participants must have a current diabetic foot ulcer, typically classified as Wagner grade 1 or 2 (superficial or deep ulcers without bone involvement).\n* Ulcer Duration: The diabetic ulcer must be chronic, generally defined as a wound that has not healed within 30 days.\n* Adequate Circulation: Participants must have sufficient blood flow to the affected limb as confirmed by non-invasive vascular tests (e.g., Ankle-Brachial Index or Doppler ultrasound).\n* Ability to Consent: Participants must be able to provide informed consent and agree to comply with study protocols, including regular clinic visits for treatment and assessments.\n\nExclusion Criteria:\n\n* Active Infection or Osteomyelitis: Presence of an active infection at the ulcer site or underlying bone infection (osteomyelitis).\n* Wagner Grade 3 or Higher: Participants with more severe ulcers, such as those extending to bone or involving gangrene, will be excluded.\n* Severe Peripheral Arterial Disease (PAD): Participants with severe ischemia, as indicated by an Ankle-Brachial Index (ABI) below a certain threshold (e.g., \\\u003C 0.5), will be excluded.\n* Use of Other Phototherapy Modalities: Participants currently receiving other forms of phototherapy, including low-level laser therapy (LLLT), will not be eligible.\n* Recent Surgery on the Affected Limb: Participants who have undergone recent surgical procedures on the ulcerated limb within the last 30 days.\n* Pregnancy: Pregnant individuals will be excluded due to the potential unknown effects of MIRE on fetal development.\n* Non-compliance Risk: Participants who are deemed unable to comply with the study protocol or follow-up schedule, due to cognitive impairment, substance abuse, or other factors.\n* Other Severe Comorbidities: Patients with severe comorbid conditions such as terminal illness or uncontrolled cardiovascular disease that may interfere with wound healing or study participation.","40 Years","70 Years",{"count":354,"type":21},[50],"The purpose of this study is to evaluate the effectiveness of monochromatic infrared energy (MIRE) as an adjunctive therapy for the healing of diabetic foot ulcers (DFUs).",[25],"2026-02-20",{"date":457,"type":30},"2026-02-24",{"date":459,"type":21},"2026-02-22",{"date":317,"type":21},{"name":462,"class":121},"Cairo University",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":17,"minAge":305,"maxAge":471,"enrollmentInfo":472,"targetDuration":4,"studyType":48,"phases":474,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":488},"100497538","trial-to-evaluate-the-safety-and-effectiveness-of-treatment-with-coms-one-device-in-subjects-with-diabetic-foot-ulcers-100497538","NCT05758545","Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers","Concurrent Optical and Magnetic Stimulation (COMS) for Treatment of Refractory Diabetic Foot Ulcer; a Prospective Randomized, Sham-controlled, Double-blinded, Pivotal Clinical Trial","Mavericks","Inclusion Criteria:\n\n1. Subjects are male or female, ≥22 and ≤90 years of age\n2. Female subjects of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at screening and throughout the duration of their study participation.\n3. The participant (or LAR if applicable) must be able to understand and sign the informed consent form (ICF) and comply with requirements set in the protocol including trial visits, trial treatment and dressing regimens and compliance with required offloading device (if applicable)\n4. Type 1 or Type 2 diabetes mellitus\n5. Presence of one full-thickness DFU located at or below the malleoli (If the subject has more than one DFU that meets eligibility criteria, the investigator will designate one DFU as the target DFU to be treated in the trial)\n6. Wagner Grade 1 or 2 (without bone exposure)\n7. There is a minimum 2 cm margin between the target DFU and any other ulcer on that same foot, post-debridement\n8. Target DFU duration \\>30 days and \\\u003C52 weeks\n9. Target DFU area between 0.5 - 25 cm2 at screening (Target DFU is ≥ 0.5cm2 after debridement at start of Run-In Phase)\n10. Adequate vascular perfusion of the target limb (same limb as where the target DFU is located) as evidenced by: either a skin perfusion pressure (SPP) measurement of ≥30mmHg OR an ankle-brachial index (ABI) \\>0.7 but less than 1.2 or a toe-brachial index (TBI) \\>0.4 but less than 1.1 or a transcutaneous oxygen pressure (TcPO2) \\>40mmHg\n\nExclusion Criteria:\n\n1. Known pregnancy or lactating\n2. Active skin cancer, a history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated.\n3. Subject who is taking any medications the Investigator believes may interfere with healing of the target DFU\n4. Subject who is currently undergoing treatment for an active systemic infection, including osteomyelitis\n5. Wagner Grade 3, 4 or 5\n6. Participation in another trial with investigational drug or device within the 30 days preceding and during the present trial\n7. Any co-morbid medical condition which places the subject at unreasonable risks in the opinion of the Investigator\n8. Subject has chronic renal insufficiency requiring dialysis (end stage renal disease)\n9. Subject is being treated with systemic corticosteroids (prednisone, dexamethasone, hydrocortisone, methylprednisolone, or similar) \\>10mg\u002Fday for more than 10 days or any dose \\>30 days\n10. For subjects in the 2-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Phase Visit I or Randomization\u002FBaseline Visit or more than 50% closure of target DFU between the 2 Week Historical Period and Randomization\u002FBaseline Visit (measured post-debridement)\n11. For subjects in the 4-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Visit II or between Screening Run-In Phase Visit II and Randomization\u002FBaseline Visit or more than 50% closure of target DFU between Screening Run-In Phase Visit I and Randomization\u002FBaseline Visit (measured post-debridement)\n12. Blood chemistry or counts values as follows (based on subject's medical files):\n\n    1. Pre-albumin \\\u003C10 mg\u002FdL OR albumin \\\u003C2.8 g\u002FdL\n    2. Serum BUN \\>60 mg\u002FdL\n    3. Serum creatinine \\>4.0 mg\u002FdL\n    4. WBC \\\u003C2.0 x 109\u002FL\n    5. Hemoglobin \\\u003C8.0 g\u002FdL\n    6. Absolute neutrophil \\\u003C1.0 x 109\u002FL\n    7. Platelet count \\\u003C50 x 109\u002FL\n    8. HbA1C \\>12%","90 Years",{"count":473,"type":21},450,[50],"The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device through 24 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.",[25],[478],"Refractory Diabetic Foot Ulcer (DFU)","2026-02-12",{"date":481,"type":30},"2026-02-17",{"date":483,"type":30},"2023-06-19",{"date":485,"type":21},"2027-06-19",{"name":487,"class":37},"Piomic Medical",30,{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":496,"enrollmentInfo":497,"targetDuration":4,"studyType":48,"phases":499,"briefSummary":501,"conditions":502,"keywords":506,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":513,"locationsCount":38},"100623418","phase-1-evaluation-of-elu42-topical-spray-for-the-treatment-of-diabetic-foot-ulcers-100623418","NCT07396376","Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers","Protocol ELU42 01 01: Phase I\u002FIIA, Open Label, Single Arm Evaluation of Topical ELU42 (XAV939 in DHA77) for Wagner Grade 1-2 Diabetic Foot Ulcers","Inclusion Criteria:\n\n* Age 18 to ≤75 years;\n* Diagnosis of type 1 or type 2 diabetes mellitus;\n* A1C ≤ 10 (historical within 2 months accepted);\n* BMI ≤ 36;\n* Index DFU Wagner grade 1-2 with post debridement area ≥1.0 cm2 and ≤8.0 cm2;\n* Index DFU present for 4-52 weeks;\n* Index ulcer ≥1 cm below malleoli;\n* Adequate perfusion per ABI\u002FTcPO2\u002FPVR\u002FTBI or Doppler; plantar ulcers off loaded ≥14 days prior to treatment;\n* Ability to consent and attend visits;\n* Contraception requirements for females of childbearing potential.\n\nExclusion Criteria:\n\n* Infected index ulcer or surrounding cellulitis;\n* Ischemic ulcers; osteomyelitis or exposed bone;\n* Recent systemic antibiotic requirement for active infection (eligibility after resolution and 7 day washout);\n* Acute\u002Finactive Charcot preventing off loading; hemoglobin \\\u003C 10 g\u002FdL (unless Sponsor approves);\n* ESRD requiring dialysis;\n* Recent\u002Fplanned vascular procedure on target leg within 30 days;\n* Participation in other IP trials within 30 days;\n* Active alcohol\u002Fsubstance abuse within 3 months;\n* Pregnancy or lactation;\n* Other PI judged exclusions","75 Years",{"count":498,"type":21},15,[500,334],"PHASE1","ELU42 01 01 (SuperHealer42) is a Phase I\u002FIIA open label study sponsored by Eluciderm, Inc. that evaluates the safety and preliminary effectiveness of ELU42, a topical small molecule designed to modulate Wnt signaling, for the treatment of chronic diabetic foot ulcers (DFU). ELU42 combines a tankyrase inhibitor (XAV939) with a novel derivatized hyaluronic acid excipient (DHA77) and is applied as a topical spray to the index ulcer.\n\nFifteen adults with Wagner grade 1-2 diabetic foot ulcers that have been present for at least 4 weeks and up to 52 weeks will be enrolled across up to four U.S. clinical sites. After a 2 week run in period during which standard of care (SOC) is provided (off loading, dressings, and debridement), subjects will receive ELU42 applied on site by trained study staff or the investigator three times per week (Monday, Wednesday, Friday) for six weeks (up to 18 applications). Subjects will be followed weekly during treatment and for up to 6 weeks after the final dose; additional Healing Confirmation visits are scheduled if the wound closes to evaluate the subjects over a course of a 3 month period.\n\nThe study's co-primary objectives are to assess safety (incidence and severity of adverse events and infections) and to measure percent area reduction (PAR) of the index ulcer at Weeks 4 and 6. Efficacy assessments will be performed by the site investigator using direct two axis planimetry and by automated evaluation using the Tissue Analytics platform (surface area, volume, and PAR). Secondary and exploratory assessments include patient reported outcomes (Wound Q and SF 36), frequency of complete wound healing, wound hydration metrics, and pharmacokinetic sampling in a subset of subjects.\n\nContact information for potential participants and referring clinicians is available at each participating site.",[25,503,504,505],"Wagner Grade 1 - 2","Chronic Wound","Open Wound",[507,504,162,505,362],"Wagner 1 and 2 Ulcer","2026-02-10",{"date":479,"type":30},{"date":511,"type":30},"2025-11-10",{"date":236,"type":21},{"name":514,"class":37},"Eluciderm Inc",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":524,"conditions":525,"keywords":528,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":143},"100620653","evaluating-the-durability-of-closure-for-diabetic-foot-ulcers-following-a-randomized-controlled-modified-platform-trial-100620653","NCT07360418","Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial.","A Prospective Multicenter Study Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial","SCANX","Inclusion Criteria:\n\n* The potential subject must have participated in the CAMPX trial and achieved complete closure by the 12-week endpoint.\n\nExclusion Criteria:\n\n* The potential subject did not participate in the CAMPX trial.\n* The potential subject participated in the CAMPX trial and did not achieve complete closure.",{"count":280,"type":21},"Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.",[526,527,261,25],"Diabetic Foot Ulcers (DFU)","Foot Ulcer Chronic",[529,530,531,161],"CAMPX","CAMP","Foot Ulcer","2026-02-09",{"date":508,"type":30},{"date":535,"type":30},"2025-10-16",{"date":537,"type":21},"2027-10",{"name":539,"class":37},"Applied Biologics, LLC",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":546,"targetDuration":4,"studyType":48,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":553,"leadSponsor":555,"locationsCount":143},"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":131,"type":21},[255],"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.",[109,531,262,162,260,259,25],{"date":551,"type":30},"2026-02-11",{"date":439,"type":30},{"date":554,"type":21},"2027-08",{"name":539,"class":37},{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":48,"phases":564,"briefSummary":565,"conditions":566,"keywords":570,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":143},"100620977","phase-4-a-multicenter-prospective-controlled-modified-multi-platform-trial-assessing-the-efficacy-of-human-placental-membrane-products-and-standard-of-care-in-the-management-of-nonhealing-diabetic-foot-ulcers-and-venous-leg-ulcers-100620977","NCT07364630","A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.","BIORESCUE","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 BIOCAMP 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 BIOCAMP 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 is taking hydroxyurea.\n* The potential subject has applied topical steroids to the ulcer surface within one month of TV-1.\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 TV-1.\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 BIOCAMP trial.\n* The potential subject participated in the BIOCAMP trial and was not randomized to the SOC only arm.\n* The potential subject participated in the BIOCAMP trial and achieved complete closure.\n* The target ulcer was treated with CAMPs, also defined as skin substitute, or hyperbaric oxygen therapy (HBOT) in the month prior to TV-1.",{"count":280,"type":21},[255],"The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care in the management of nonhealing diabetic foot ulcers and venous leg ulcers.",[25,527,162,262,567,364,568,569,261],"Venous Leg Ulcer (VLU)","Venous Ulcer","Leg Ulcers",[571,261,568,572,573,162,25,531,574],"Leg Ulcer","Venous Leg ulcer","VLU","Diabetic foot","2026-02-05",{"date":532,"type":30},{"date":578,"type":30},"2026-01-02",{"date":580,"type":21},"2027-01",{"name":582,"class":37},"BioLab Holdings",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":48,"phases":591,"briefSummary":592,"conditions":593,"keywords":596,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":297},"100497837","diabetic-foot-ulcer-research-study-100497837","NCT05762432","Diabetic Foot Ulcer Research Study","A Pilot Open Label Prospective, Randomised, Study to Evaluate the Safety and Efficacy of Keneric Healthcare RTD Wound Dressing in the Treatment of Diabetic Foot Ulcers Compared to Standard of Care","Inclusion Criteria:\n\n* Male or female, aged ≥18 years old with a diagnosis of type 1 or type 2 diabetes.\n* New presentation for treatment of a neuropathic, ischaemic or neuro- ischaemic non- infected DFU\n* Subjects must be able to follow verbal and written instructions in English\n* Subjects must have full mental capacity and able to give written informed consent to participation in the trial including medical photography for the purposes of the clinical trial or clinical care.\n* DFU is \\>10mm2 and \\\u003C100mm2\n\nExclusion Criteria:\n\n* Known allergy\u002Fhypersensitivity to any ingredient contained in the Keneric healthcare RTD Wound Dressing\n* Participants who will have problems following the protocol, including the offloading system, provided as standard of care, to wear on a daily basis\n* Suspected malignancy in the wound\n* Critical limb ischaemia\n* Pregnant or breastfeeding females\n* Women of childbearing potential and not using a medically accepted form of contraception when sexually active.",{"count":20,"type":21},[50],"The goal of this clinical trial is to compare safety and performance of the study device to the current typical NHS standards of care device. The main outcomes it aims to achieve are:\n\nComplete wound healing at 12 weeks (100% epithelialised)\n\n% Reduction in wound area at 12 weeks\n\nParticipants will attend their NHS podiatry clinic appointment as normal and will be assigned either the study device or the current typical NHS standard of care device. Researchers will compare the study device group to the standard group to assess the outcomes mentioned previously.",[25,594,595],"Diabetic Foot Ulcer Neuropathic","Diabetic Foot Ulcer Ischemic",[185,531,25],"2026-01-23",{"date":599,"type":30},"2026-01-26",{"date":601,"type":30},"2024-04-26",{"date":603,"type":21},"2027-01-01",{"name":605,"class":121},"Community Pharmacology Services Ltd",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":48,"phases":615,"briefSummary":616,"conditions":617,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":38},"100397857","phase-2-smart-boot-use-to-measure-offloading-adherence-100397857","NCT04460573","Smart Boot Use to Measure Offloading Adherence","Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading","Inclusion Criteria:\n\n* Male or female\n* ≥18 years old\n* Non-infected, non-ischemic DFU requiring offloading\n* Ambulatory at home with or without assistance\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Wound present for \\> 1 year\n* HbA1c \\> 12%\n* ABI of index limb \\\u003C 0.6 or non-detectable Doppler, and\u002For patient being considered for revascularization during the course of the study\n* Acute Charcot neuropathy or a major foot deformity that doesn't allow them to wear the smart boot\n* Amputation proximal to the rearfoot on the affected extremity\n* Any clinically significant medical or psychiatric condition\n* Laboratory abnormality that would interfere with the ability to participate in the study\n* Concurrently participating in exercise training\n* Changes in psychotropic or sleep medication in the last 6 weeks\n* Ulcer involves bone\n* Ulcer not of diabetic origin\n* Unable or unwilling to attend prescribed clinic visits or comply with protocol",{"count":614,"type":21},210,[334],"The purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (DFUs). These ulcers, or sores, if left untreated can increase the chance of amputation. Part of the treatment is to have the person wear a diabetic shoe or boot to help their foot heal. Sometimes people don't wear the boot like they are told. The investigators want to compare three different kinds of diabetic boots to see if they can help make it easier for people to wear their boots as instructed.\n\nThe investigators will look at three groups of participants: the first group will use removable offloading with reinforced education emphasizing continuous wear, including during rest and sleep, and not to remove it at any time. The second group will use removable offloading consistent with standard of care and receive education on recommended wear during walking or standing, with permission to remove the device during rest and sleep. The third group will use a smart removable offloading device that provides real-time adherence feedback via a smartwatch and smartphone, with additional personalized education informed by remotely monitored adherence data.\n\nThe investigators will also be looking at how much physical activity, like walking, the participants do. And they will compare how well participants sleep and rate their quality of life in the three different boots. The investigators think that giving participants information about how much they are wearing their boot using readily available technology will help them to follow the doctor's directions better, and help their wounds heal faster.",[25],"2026-01-14",{"date":620,"type":30},"2026-01-16",{"date":622,"type":30},"2021-10-19",{"date":624,"type":21},"2026-03-31",{"name":626,"class":121},"University of Southern California"]