[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"foot-ulcer-due-to-type-2-diabetes-mellitus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:foot-ulcer-due-to-type-2-diabetes-mellitus":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,76,98,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100599588","phase-4-randomized-evaluation-of-nonhealing-diabetic-foot-ulcers-with-exclusive-wound-therapy-100599588",false,"NCT07086443","Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating Placental Derived Allografts and Standard of Care in the Treatment of Nonhealing Diabetic Foot Ulcers Using Matched Controls","RENEW","Inclusion Criteria:\n\n* The potential subject must be at least 18 years of age or older.\n* The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.\n* At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the imaging device length times width.\n* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.\n* The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.\n* The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.\n* The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n  1. ABI between 0.7 and ≤ 1.3;\n  2. TBI ≥ 0.6;\n  3. TCOM ≥ 40 mmHg;\n  4. PVR: biphasic. 8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n* The potential subject must have a target ulcer located on the 50% below the malleolus and not on the dorsal toes.\n* The ulcer must be offloaded for at least 14 days prior to enrollment.\n* The potential subject must consent to using the prescribed offloading method for the duration of the study.\n* The potential subject must agree to attend the weekly study visits required by the protocol.\n* The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n* The potential subject is known to have a life expectancy of \\\u003C 6 months.\n* The potential subject's target ulcer is not secondary to diabetes.\n* The target ulcer is infected or there is cellulitis in the surrounding skin.\n* The target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the target ulcer.\n* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n* The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n* The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n* The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.\n* The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.\n* The potential subject has end stage renal disease requiring dialysis.\n* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n* The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n* The potential subject has a malnutrition.\n* The potential subject has a known allergy or sensitivity to PBS, IPA, processing solutions, reagents, or latex.","ALL","18 Years",{"count":20,"type":21},350,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32,33],"Diabetic Foot Ulcer","DFU","Diabetic Foot Ulcer (DFU)","Foot Ulcer Due to Type 1 Diabetes Mellitus","Foot Ulcer Due to Type 2 Diabetes Mellitus","Ulcer","Ulcer Foot","RECRUITING","2026-05-18",{"date":37,"type":38},"2026-05-19","ACTUAL",{"date":40,"type":38},"2025-07-11",{"date":42,"type":21},"2027-07",{"name":44,"class":45},"Sequence LifeScience, Inc.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":46},"100638911","phase-3-effect-of-semaglutide-on-healing-of-foot-ulcers-in-type-2-diabetes-patients-100638911","NCT07581145","Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients","The SEMAFOOT2 Pilot Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients","SEMAFOOT2","Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes mellitus for at least 6 months\n* Age 18-90 years\n* A foot ulcer below the level of the malleoli. If more than one ulcer, the largest will be selected at screening as the index ulcer.\n* Wound area after sharp debridement of ≥ 5 mm2, but ≤ 3000 mm2.\n\nExclusion Criteria:\n\n* Current use, or recent use (\\\u003C3 months), of GLP-1 agonists\n* Current use of DPP-IV inhibitors\n* Previous acute pancreatitis\n* Signs of infection of the index ulcer\n* Toe blood pressure \\\u003C 40 mmHg at the foot with the index ulcer\n* Current treatment with cytotoxic drugs or with systemically administered glucocorticoids\n* Hospitalisation for a major cardiovascular event or procedure or revascularization surgery on a leg in the last 3 months, or scheduled major cardiovascular intervention\n* Contraindication\u002Fintolerance to study medication\n* Pre-existing medical condition judged to preclude safe participation in the study\n* Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocol\n* Recent use (\\\u003C 3 months) of an investigational drug or participation in interventional clinical foot ulcer-healing trial\n* Known pregnancy, breast feeding or planning pregnancy.\n* Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) without a confirmed menstrual period or with a positive highly sensitive pregnancy test).\n* Women of childbearing potential not using highly effective birth control methods, such as combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence).\n* Men, with female partners of childbearing potential, not vasectomised or not using condoms or sexual abstinence AND the female partner not using highly effective birth control, such as combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion).\n* Likely inability to comply with the need for weekly visits because of planned activity\n* Mental incapacity, unwillingness, not speaking and understanding Danish or language barrier precluding adequate understanding or cooperation\n* Unable to provide written and signed informed consent.\n* Use of any drug which in the Investigator's opinion could interfere with the healing of foot ulcers.\n* Any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial\n* Active cancer or a history of cancer in the 3 years prior to signing the informed consent form (history of basal cell carcinoma is allowed).\n* Life expectancy of less than 12 months.\n* Wounds caused primarily by untreated vascular insufficiency, or where patients are primarily eligible for vascular intervention to promote wound healing.\n* Wounds with an etiology not related to diabetes.\n* Underlying osteomyelitis of the leg with the wound to be treated.\n* Patients presenting with the clinical characteristics of cellulitis at the wound site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever).\n* Surgery to lengthen Achilles tendon on the leg with the wound to be treated 3 months prior to signing the informed consent form.\n* Necrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated.","90 Years",{"count":57,"type":21},52,[59],"PHASE3","The aim of this exploratory pilot study is to investigate the effect of semaglutide compared to placebo on healing of foot ulcers in type 2 diabetes patients.\n\nIt is a randomized double blind, placebo controlled, clinical intervention study of 20 weeks intervention.",[31],[63,64,65],"semaglutide","randomized clinical trial","diabetic foot ulcer","2026-05-06",{"date":68,"type":38},"2026-05-12",{"date":70,"type":38},"2026-04-24",{"date":72,"type":21},"2029-12",{"name":74,"class":75},"Ole Lander Svendsen","OTHER",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":46},"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":83,"type":21},60,[24],"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.",[87,88,33,28,31,30,27],"Diabetic Foot","Foot Ulcer","2026-02-09",{"date":91,"type":38},"2026-02-11",{"date":93,"type":38},"2025-08-26",{"date":95,"type":21},"2027-08",{"name":97,"class":45},"Applied Biologics, LLC",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":111,"conditions":112,"keywords":119,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":46},"100486191","phase-1-efficacy-of-adipose-tissue-derived-stem-cells-for-the-treatment-of-diabetic-foot-ulcers-100486191","NCT05610865","Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers","Autologous Adipose Tissue Derived Stromal Vascular Fraction Versus Cultured Adipose Derived Stem Cells for the Treatment of Chronic Diabetic Wounds","Inclusion Criteria:\n\n* Type 1 or Type 2 Diabetes Mellitus\n* Age 20-60 years (Male\u002FFemale)\n* Body mass index 20-30 kg\u002Fm2\n* Suitable for liposuction\n* Condition or Disease: Diabetic Neuropathy\n* Wound Type: Chronic foot ulcer\n* Approx. wound area: 2 cm2 - 8 cm2\n* Wound Condition should be of Wagner's grade I (Limited to soft tissue)\n* Duration of wound persistence: 6-24 Weeks\n* Transcutaneous oxygen pressure \\> 30 mmHg, and an ankle brachial pressure index \\> 0.5.\n* Already following an adequate off-loading method\n* Provided signed informed consent\n\nExclusion Criteria:\n\n* Uncontrolled hyperglycemia (HbAlc \\> 9%)\n* Presence of severe clinical sign of infection\n* Inability to tolerate off-loading, and poor prognosis diseases including malignant tumors.\n* Serious chronic disease i.e hepatic, heart, renal, pulmonary diseases\n* Patients with critical limb ischemia and osteomylitis\n* Withdrawal of informed consent","20 Years","60 Years",{"count":108,"type":21},28,[110],"PHASE1","The aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (SVF) and cultured adipose derived stem cells (ASCs) both supplemented with platelet rich plasma (PRP) to treat chronic diabetic foot ulcers. It will increase the pragmatic potential of both types of cells as PRP is rich in survival and chemotactic factors. Moreover, the autologous nature of the proposed study will ensure safety of its use in diabetic patients and will unveil the more effective therapeutic option for treatment of foot ulcer wounds.",[27,113,87,114,115,30,31,88,116,117,118],"Diabetes Mellitus","Diabetic Foot Infection","Diabetic Foot Ulcer Neuropathic","Diabetes Complications","Chronic Diabetic Ulcer of Left Foot","Chronic Diabetic Foot Ulcer of Right Foot",[120],"Stromal vascular fraction (SVF), Adipose derived stem cells (ASCs), Diabetic foot ulcer (DFU), Platelet rich plasma (PRP)","2024-12-30",{"date":123,"type":38},"2024-12-31",{"date":125,"type":38},"2020-11-20",{"date":127,"type":21},"2025-12",{"name":129,"class":75},"University of the Punjab",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":46},"100562250","modified-platform-trial-evaluating-pplhacm-and-soc-versus-soc-alone-in-the-treatment-of-nonhealing-dfus-100562250","NCT06600724","Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating PURION Processed Lyophilized Human Amnion\u002FChorion Membrane (ppLHACM) and Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers","CAMPAIGN","Inclusion Criteria:\n\n1. At least 18 years of age or older.\n2. Diagnosis of type 1 or 2 Diabetes mellitus.\n3. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm\\^2 and a maximum surface area of 5.0 cm\\^2 measured post debridement.\n4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.\n5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.\n6. The target ulcer must be 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.\n7. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3;\n   2. Toe-Brachial Index (TBI) ≥ 0.6;\n   3. Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg;\n   4. Pulse Volume Resistance (PVR): biphasic.\n8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.\n10. The potential subject must consent to using the prescribed offloading method for the duration of the study.\n11. The potential subject must agree to attend the weekly study visits required by the protocol.\n12. The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n1. The potential subject is known to have a life expectancy of \\\u003C 6 months.\n2. The potential subject's target ulcer is not secondary to diabetes.\n3. The target ulcer is infected or there is cellulitis in the surrounding skin.\n4. The target ulcer exposes tendon or bone.\n5. There is evidence of osteomyelitis complicating the target ulcer.\n6. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n7. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n8. The potential subject is taking hydroxyurea.\n9. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n10. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n11. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n12. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). MolecuLight Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n13. The surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.\n14. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n15. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.\n16. The potential subject has end stage renal disease requiring dialysis.\n17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.\n18. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n19. The 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.\n20. The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n21. A subject has a wound with active or latent infection is excluded.\n22. A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.\n23. A subject with a known sensitivity to aminoglycoside antibiotics is excluded.",{"count":139,"type":21},170,[141],"NA","This study will evaluate two human amnion\u002Fchorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).",[27,87,31,144,88],"Foot Ulcer, Diabetic",[32,88,27,146],"Foot","2024-09-16",{"date":149,"type":38},"2024-09-19",{"date":151,"type":38},"2024-08-27",{"date":153,"type":21},"2026-08",{"name":155,"class":45},"MiMedx Group, Inc."]