[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"foot-ulcer-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:foot-ulcer-chronic":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,79],{"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":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":46},"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":20,"type":21},"INTERVENTIONAL",[57],"PHASE4","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.",[28,26,60,61,62,63,64,65,27],"DFU","Ulcer Foot","Venous Leg Ulcer (VLU)","Venous Leg Ulcer","Venous Ulcer","Leg Ulcers",[67,27,64,68,69,60,28,32,70],"Leg Ulcer","Venous Leg ulcer","VLU","Diabetic foot","2026-02-05",{"date":35,"type":38},{"date":74,"type":38},"2026-01-02",{"date":76,"type":21},"2027-01",{"name":78,"class":45},"BioLab Holdings",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":55,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100618048","phase-4-efficacy-of-placental-membrane-dressings-in-accelerating-diabetic-foot-healing-100618048","NCT07326553","Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing","A Randomized, Open-Label Trial Evaluating the Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing Compared to Matched Historical Controls Receiving Standard of Care","Inclusion Criteria.\n\n1. Patient has signed the informed consent form.\n2. Male or female patient at least 18 years of age or older, as of the date of the screening visit.\n3. Confirmed diagnosis of Type 1 or Type 2 DM.\n4. Has a DFU that is located below the malleoli ranging in size from 1.0 cm2 to 20.0 cm2, post debridement, when measured by the investigator staff at the screening visit using the eKare device.\n5. The DFU has been present for ≥4 weeks and ≤12 months.\n6. The DFU is non-healing as defined as \\\u003C30% reduction in size in response to standard of care from Screening (Visit 1) to Study Day 1 (Visit 2).\n7. If more than one ulcer is present the selected target ulcer must be at least 2 cm from the nearest edge of any adjacent ulcers.\n8. The depth of the target foot ulcer is graded as Wagner Grade I or II, i.e., with no evidence of exposed muscle, tendon, bone, or joint capsule.\n9. Arterial supply adequacy to the foot with the target ulcer confirmed by any one of the following and documented in medical record\u002FEMR:\n\n   1. Great toe pressure ≥ 40 mm\u002FHg\n   2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.70 ≤ 1.20\n   3. TcPO2 ≥ 30 mmHg from the foot\n   4. Toe Brachial Index or TBI ≥ 0.65\n10. Willing to follow all instructions given by the Investigator, return for all visits, and adhere to off-loading protocols while on the study.\n\nExclusion Criteria\n\n1. Hemoglobin A1c (HbA1c) level is \\> 10%.\n2. Chronic oral steroid use of \\> 7.5 mg daily within the previous 30 days preceding screening.\n3. Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.\n4. Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).\n5. Has malignancy or history of cancer in 5 years preceding the screening visit other than non- melanoma skin cancer.\n6. Pregnant or lactating women.\n7. Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.\n8. Currently on dialysis or planning to start dialysis.\n9. Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.\n10. Has used wound treatments with enzymes, growth factors, living skin, dermal substitutes including other amniotic or umbilical cord tissue therapies, or other advanced biological therapies within the last 30 days.\n11. Current use of topical anti-microbial or silver-containing products.\n12. Target ulcer is over an active or inactive Charcot deformity.\n13. The depth of the target ulcer is graded as Wagner Grade III or higher, i.e., with evidence of exposed muscle, tendon, bone, and\u002For joint capsule.\n14. Gangrene is present on any part of the affected foot.\n15. Current suspicion of osteomyelitis, cellulitis, or other clinical signs or symptoms of target ulcer infection.\n16. Any previous use of human placental membrane applied to the target ulcer.","45 Years","85 Years",{"count":89,"type":21},30,[57],"Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing",[93,26],"Diabete Mellitus","2026-01-07",{"date":96,"type":38},"2026-01-08",{"date":98,"type":38},"2025-12-01",{"date":100,"type":21},"2026-12-31",{"name":102,"class":45},"BioXTek",2]