[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Applied Biologics, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":113},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,72,92],{"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":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100620653","evaluating-the-durability-of-closure-for-diabetic-foot-ulcers-following-a-randomized-controlled-modified-platform-trial-100620653",false,"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.","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","OBSERVATIONAL","Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.",[25,26,27,28],"Diabetic Foot Ulcers (DFU)","Foot Ulcer Chronic","Ulcer","Diabetic Foot Ulcer",[30,31,32,33],"CAMPX","CAMP","Foot Ulcer","diabetic foot ulcer","RECRUITING","2026-02-09",{"date":37,"type":38},"2026-02-10","ACTUAL",{"date":40,"type":38},"2025-10-16",{"date":42,"type":21},"2027-10",{"name":44,"class":45},"Applied Biologics, LLC","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"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":54,"type":21},60,"INTERVENTIONAL",[57],"PHASE4","A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.",[60,32,61,62,63,64,28],"Diabetic Foot","Ulcer Foot","DFU","Foot Ulcer Due to Type 2 Diabetes Mellitus","Foot Ulcer Due to Type 1 Diabetes Mellitus",{"date":66,"type":38},"2026-02-11",{"date":68,"type":38},"2025-08-26",{"date":70,"type":21},"2027-08",{"name":44,"class":45},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":55,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":91,"locationsCount":46},"100602697","phase-4-a-multicenter-prospective-clinical-trial-evaluating-a-single-layer-amniotic-membrane-and-standard-of-care-versus-matched-controls-in-the-management-of-nonhealing-pressure-ulcers-100602697","NCT07126886","A Multicenter, Prospective, Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care Versus Matched Controls in the Management of Nonhealing Pressure Ulcers","Inclusion Criteria:\n\n* The potential subject must be at least 18 years of age or older.\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 a full thickness pressure ulcer NPIAP stage 3 through stage 4 without exposed bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial).\n* At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100 cm2 measured post debridement with the imaging device.\n* The potential subject has adequate off-loading of the ulcer.\n\nExclusion Criteria:\n\n* The potential subject is known to have a life expectancy of \\\u003C 3 months.\n* The potential subject's target ulcer is not a pressure ulcer.\n* The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n* The target ulcer exposes tendon or bone.\n* There is undermining at the wound edge or tunnelling.\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 has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit(For diabetics only).\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 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* The potential subject has a known or suspected sensitivity to glutaraldehyde solutions.",{"count":79,"type":21},100,[57],"A multicenter, prospective, clinical trial evaluating a single-layer amniotic membrane (XPURT) and standard of care versus matched controls in the management of nonhealing pressure ulcers.",[83,84,85,86],"Pressure Ulcer","Ulcer, Pressure","Pressure Wound","Pressure Area",{"date":66,"type":38},{"date":89,"type":38},"2025-06-11",{"date":70,"type":21},{"name":44,"class":45},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":55,"phases":101,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":46},"100559492","evaluating-the-efficacy-of-a-single-layer-placental-based-allograft-and-standard-of-care-versus-standard-of-care-100559492","NCT06564831","Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care","A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers","Inclusion Criteria:\n\n1. Subjects must be at least 18 years of age or older,\n2. Subjects must have a 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 cm2 and a maximum surface area of 20.0 cm2 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 Wager 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. ABI ≥ 0.7 and ≤ 1.3;\n   2. TBI ≥ 0.6;\n   3. TCOM ≥ 40 mmHg;\n   4. PVR: biphasic.\n8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n9. The subject must consent to using the prescribed off-loading method for the duration of the study.\n10. The subject must agree to attend the weekly study visits required by the protocol.\n11. The subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n1. A subject known to have a life expectancy of \\\u003C 6 months is excluded.\n2. The subject is excluded if the target ulcer is not secondary to diabetes.\n3. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.\n4. If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.\n5. A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n6. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.\n7. The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.\n8. A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.\n9. The potential subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n10. The subject is excluded if 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). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).\n11. The subject is excluded if 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\u002Frandomization visit during which time the subject received SOC.\n12. A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.\n13. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.\n14. A potential subject with end stage renal disease requiring dialysis is excluded.\n15. A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.\n16. A Subject treated with hyperbaric oxygen therapy or a Cellular and\u002For Tissue Product (CTP) in the 30 days prior to the initial screening visit is excluded.\n17. The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.",{"count":100,"type":21},124,[102],"NA","A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers",[28,60,32,61,62],"2024-11-18",{"date":107,"type":38},"2024-11-20",{"date":109,"type":38},"2024-09-20",{"date":111,"type":21},"2025-08",{"name":44,"class":45},""]