[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"foot-ulcer-diabetic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:foot-ulcer-diabetic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,69,98,123,146,171],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100358055","diabetic-foot-ulcer-imaging--study-2-100358055",false,"NCT03942081","Diabetic Foot Ulcer Imaging- Study 2","Testing the Accuracy and Feasibility of Diabetic Foot Ulcer Imaging","Inclusion Criteria:\n\n* Diagnosed with Type 1 or Type 2 Diabetes\n* Has a current foot lesion\n* Receiving care through University of Iowa Hospitals and Clinics (UIHC) Iowa River Landing Diabetes Clinic, UIHC Internal Medicine Clinic, or UIHC Orthopedic Clinic.\n\nExclusion Criteria:\n\n* Cognitive impairment that prevents consent\n* Lack of fluency in speaking or understanding English\n* Known aversion to research studies","ALL","21 Years","100 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"NA","All study procedures will occur during one appointment. The research team will measure the size of the foot ulcer (if one is present) and multiple photos will be taken with a smart phone camera and thermal camera. Demographic information will be obtained from the medical record.",[27,28],"Foot Ulcer","Foot Ulcer, Diabetic","RECRUITING","2025-12-30",{"date":32,"type":33},"2026-01-02","ACTUAL",{"date":35,"type":33},"2017-09-05",{"date":37,"type":21},"2026-07",{"name":39,"class":40},"Linnea Polgreen","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":41},"100378633","total-contact-soft-cast-in-diabetic-foot-ulcers-100378633","NCT04210089","Total Contact Soft Cast in Diabetic Foot Ulcers","Inclusion Criteria:\n\n\\- Any adult with a diabetic foot ulcer\n\nExclusion Criteria:\n\n* Allergy to Calamine or Zinc oxide\n* Inability to have leg wrapped\n* Inability to be seen weekly or as needed\n* Unable or unwilling to consent\n* Prisoners\n* Persons lacking capacity to consent","18 Years",{"count":50,"type":21},100,[24],"To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.",[54,55,27,28,56,57,58,59],"Diabetic Foot Ulcer","Diabetes Mellitus","Ulcer","Ulcer Foot","Ulcer, Leg","Ankle Ulcer","2025-12-09",{"date":62,"type":33},"2025-12-15",{"date":64,"type":33},"2020-10-13",{"date":66,"type":21},"2026-10-01",{"name":68,"class":40},"University of Minnesota",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":41},"100599831","phase-4-trial-assessing-the-efficacy-of-human-placental-membrane-products-and-standard-of-care-versus-standard-of-care-alone-in-the-management-of-nonhealing-diabetic-foot-ulcers-and-venous-leg-ulcers-100599831","NCT07089602","Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers","A Multicenter, Prospective, Randomized Controlled Modified Multi- Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers","BIOCAMP","Inclusion Criteria:\n\n* The potential subject must be at least 18 years of age or older.\n* The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.\n* At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20 cm2 measured post debridement with the eKare inSight® imaging device.\n* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.\n* The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.\n* The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.\n* The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n  1. ABI between 0.7 and ≤ 1.3;\n  2. TBI ≥ 0.6;\n  3. TCOM ≥ 40 mmHg;\n  4. PVR: biphasic.\n* If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n* The potential subject must consent to using the prescribed offloading method for the duration of the study.\n* The potential subject must agree to attend the weekly study visits required by the protocol.\n* The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria: DFU\n\n* The potential subject is known to have a life expectancy of \\\u003C 6 months.\n* The potential subject's target ulcer is not secondary to diabetes.\n* The target ulcer is infected or there is cellulitis in the surrounding skin.\n* The target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the target ulcer.\n* There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n* The potential subject is taking hydroxyurea.\n* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n* The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n* The surface area of the potential subject's target ulcer has reduced in size by more than 40% in the 4 weeks prior to Treatment Visit 1 (\"historical\" run-in period\\*). OR The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit AND The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV-1 visit.\n\n  a. eKare inSight® imaging device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable)\n* The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.\n* The potential subject has end stage renal disease requiring dialysis.\n* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n* The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n* The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n\nInclusion Criteria:VLU\n\n* The potential subject must be at least 21 years of age or older.\n* At enrollment, the potential subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.\n* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care prior to the initial screening visit.\n* The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n  1. ABI between 0.7 and ≤ 1.3;\n  2. TBI ≥ 0.6;\n  3. TCOM ≥ 40 mmHg;\n  4. PVR: biphasic.\n* If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n* The potential subject must agree to attend the weekly study visits required by the protocol.\n* The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n* The potential subject is known to have a life expectancy of \\\u003C 6 months.\n* The potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n* The potential subject's target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the potential subject's target ulcer.\n* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n* The surface area of the potential subject's target ulcer has reduced in size by more than 40% in the 4 weeks prior to Treatment Visit 1 (\"historical\" run-in period\\*). OR The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit AND The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV1) to the TV-1 visit.\n\n  a. \\*eKare inSight® imaging device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable)\n* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.\n* The potential subject has end stage renal disease requiring dialysis.\n* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n* A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n* The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n* The potential subject has a wound with active or latent infection.\n* The subject has a disorder that would create unacceptable risk of post-operative complication.",{"count":78,"type":21},650,[80],"PHASE4","The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.",[83,84,54,28,57,85,86,87,56],"Diabetic Foot","DFU","Venous Leg Ulcer","Leg Ulcer","Leg Ulcers Venous","2025-07-24",{"date":90,"type":33},"2025-07-28",{"date":92,"type":33},"2025-07-15",{"date":94,"type":21},"2027-07",{"name":96,"class":97},"BioLab Holdings","INDUSTRY",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100553568","evaluating-a-lifestyle-intervention-to-prevent-recurrence-of-diabetic-foot-ulcers-100553568","NCT06487780","Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers","Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers: A Pilot Study","Inclusion Criteria:\n\n* Age \\>= 21 years\n* Healed diabetic foot ulcer within the past twelve months\n* Able to walk independently (use of a cane is acceptable)\n\nExclusion Criteria:\n\n* Current active diabetic foot ulcer\n* History of amputation beside toe or part of the foot\n* Non-ambulatory at baseline\n* Self-reported deafness\u002Fblindness.",{"count":106,"type":21},60,[24],"People with diabetes often experience foot ulcers, which can harm their ability to move, lower their quality of life, and increase the chances of losing a limb. These diabetic foot ulcers (DFUs) commonly come back (recur) even after they've healed, so it's crucial to stop them from returning to avoid toe, foot , or leg amputation. While wearing special shoes to reduce pressure on the feet is essential for healing and preventing DFUs, many people struggle to follow this treatment plan once their ulcers have healed. This study aims to see if a lifestyle-focused program can help participants create daily routines and habits that make it easier to consistently use special shoes and take care of their diabetes and feet to prevent ulcers from recurring.",[83,54,28,110],"Foot Wound",[112],"Diabetic foot ulcer, lifestyle intervention","2025-06-20",{"date":115,"type":33},"2025-06-22",{"date":117,"type":33},"2025-06-11",{"date":119,"type":21},"2026-06-30",{"name":121,"class":40},"University of Southern California",3,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":41},"100579595","phase-4-evaluating-several-cellular-acellular-and-matrix-like-products-camps-and-standard-of-care-versus-standard-of-care-alone-in-the-management-of-nonhealing-diabetic-foot-and-venous-leg-ulcers-100579595","NCT06826339","Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.","A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.","Inclusion Criteria:(DFU)\n\n* Subjects The potential subject must be at least 21 years of age or older.\n* The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.\n* At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.\n* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.\n* The potential subject must have a target ulcer located on the foot with at least 50% of the ulcer below the malleolus.\n* The potential subject must have a target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus.\n* The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n  1. ABI between 0.7 and ≤ 1.3;\n  2. TBI ≥ 0.6;\n  3. TCOM ≥ 40 mmHg;\n  4. PVR: biphasic.\n* If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer. The potential subject must have a target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.\n* The potential subject must consent to using the prescribed offloading method for the duration of the study.\n* The potential subject must agree to attend the weekly study visits required by the protocol.\n* The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria: (DFU)\n\n* The potential subject is known to have a life expectancy of \\\u003C 6 months.\n* The potential subject's target ulcer is not secondary to diabetes.\n* The potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n* The potential subject's target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the potential subject's target ulcer.\n* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n* The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n* The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). EKare Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n* The surface area measurement of the potential subject's target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.\n* The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.\n* The potential subject has end stage renal disease requiring dialysis.\n* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n* A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n* The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n* The potential subject has a wound with active or latent infection.\n* The potential subject has a disorder that would create unacceptable risk of post-operative complication.\n\nInclusion Criteria:(VLU)\n\n* The potential subject must be at least 21 years of age or older.\n* At enrollment, the potential subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.\n* The potential subject must have a target ulcer that has been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.\n* The potential subject has no visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.\n* The potential subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n  1. ABI between 0.7 and ≤ 1.3;\n  2. TBI ≥ 0.6;\n  3. TCOM ≥ 40 mmHg;\n  4. PVR: biphasic.\n* If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n* The potential subject must agree to attend the weekly study visits required by the protocol.\n* The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria: (VLU)\n\n* The potential subject is known to have a life expectancy of \\\u003C 6 months.\n* The potential subject's target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n* The potential subject's target ulcer exposes tendon or bone.\n* There is evidence of osteomyelitis complicating the potential subject's target ulcer.\n* The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n* The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n* The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n* The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). EKare Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n* The surface area measurement of the potential subject's target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.\n* The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.\n* The potential subject has end stage renal disease requiring dialysis.\n* The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n* A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n* The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n* The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n* The potential subject has a wound with active or latent infection.\n* The subject has a disorder that would create unacceptable risk of post-operative complication.",{"count":131,"type":21},340,[80],"Title A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care versus Standard of Care alone in the Management of Nonhealing Diabetic Foot and Venous Leg Ulcers.",[85,135,83,54,28,57,86,136,56],"Venous Leg","Ulcer Venous","2025-02-12",{"date":139,"type":33},"2025-02-13",{"date":141,"type":33},"2024-12-06",{"date":143,"type":21},"2027-12",{"name":145,"class":97},"Tiger Biosciences, LLC.",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":41},"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":155,"type":21},170,[24],"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).",[54,83,159,28,27],"Foot Ulcer Due to Type 2 Diabetes Mellitus",[56,27,54,161],"Foot","2024-09-16",{"date":164,"type":33},"2024-09-19",{"date":166,"type":33},"2024-08-27",{"date":168,"type":21},"2026-08",{"name":170,"class":97},"MiMedx Group, Inc.",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":188,"leadSponsor":190,"locationsCount":41},"100456803","flexor-tenotomy-and-ulcer-recurrence-100456803","NCT05228340","Flexor Tenotomy and Ulcer Recurrence","The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial","Inclusion Criteria:\n\n* A minimum age of 18 years\n* Sufficient understanding of Dutch\u002FEnglish language\n* Capable of filling out informed consent\n* Peripheral polyneuropathy\n* Diabetes mellitus type 1 or 2\n* A minimum of one claw\u002Fhammer toe\n* A documented history of diabetic ulcers underneath the toe apex in the past 5 years\n\nExclusion Criteria:\n\n* No written informed consent\n* Not meeting the inclusion criteria\n* Open ulcers on the toes\n* Previous participation in the study\n* Pregnant women\n* Concomitant participation in a study in which the patient is exposed to X-rays",{"count":179,"type":21},66,[24],"The main purpose of this study is to assess the efficacy of flexor tenotomy on the prevention of recurrence of toe ulcers in people with diabetes and a history of toe ulceration. Additionally, the investigators aim to assess interphalangeal joints (IPJ) and metatarsophalangeal joint (MTPJ) angles in a weight-bearing and non-weight-bearing position, bare-foot plantar pressure during walking and quality of life before and after the intervention and compare between study groups.",[183,28],"Hammer Toe Syndrome","2022-03-15",{"date":186,"type":33},"2022-03-29",{"date":184,"type":33},{"date":189,"type":21},"2027-02",{"name":191,"class":40},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"]