[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"wound-foot\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:wound-foot":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,72,112],{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100645480","campr-ii-rwe-trial-a-saline-hydrated-allogeneic-dual-layer-amniotic-membrane-product-or-a-synthetic-resorbable-polymeric-wound-matrix-to-a-coarsened-exact-matched-retrospective-control-cohort-of-hard-to-heal-dfus-and-vlus-100645480",false,"NCT07701590","CAMPR-II RWE TRIAL: A Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Hard to Heal DFUs and VLUs","A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs","CAMPR-II","Inclusion Criteria:\n\n1. Male or female 18 years of age and older\n2. If a female is not currently pregnant or breastfeeding nor plans to become pregnant during the study and is either not of childbearing potential (defined as: postmenopausal \\[defined as amenorrhea for at least 1 year and serum follicle stimulating hormone (FSH) level \\>40 IU\u002FL\\], or surgically sterile \\[bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or tubal ligation at least 6 months prior to IP administration\\]), or is practicing one or more of the following medically acceptable methods of birth control throughout the study.\n\n   1. Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on subject's usual menstrual cycle period) before Screening\u002FRandomization Visit and must follow that product's package insert instructions including additional protection at times when hormonal contraceptive doses might be missed.\n   2. Total abstinence from sexual activities that can lead to pregnancy for at least 6 months prior to Screening\u002FRandomization Visit. Abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle.\n   3. Intrauterine device\n   4. Vasectomized Partner (for at least 6 months)\n   5. Double-barrier method (condoms and clerical cap with spermicidal jellies or cream or condoms and diaphragm with spermicidal jellies or cream or condoms and contraceptive foam).\n3. Negative pregnancy test for all subjects of childbearing potential\n4. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of \\>4 weeks duration.\n5. No visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks\n6. Subjects' wound size is minimum of 2 cm2 and maximum of 24cm2\n7. If the subject has more than one eligible wound the largest wound will be selected (the index wound)\n8. Subject is able and willing to follow the protocol requirements\n9. Subject has signed informed consent.\n\nExclusion Criteria:\n\n1. Inability to adhere to the study protocol or study visit schedule\n2. Pregnancy\n3. Child-bearing potential without appropriate contraception\n4. Lactation\n5. Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.\n6. Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)\n7. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety\n8. Known contraindications to the use of either IP1 or IP2\n9. The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics.","ALL","18 Years",{"count":20,"type":21},147,"ESTIMATED","INTERVENTIONAL",[24],"NA","CAMPR-II Trial: A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a saline-hydrated allogeneic dual-layer amniotic membrane product or a synthetic, resorbable polymeric wound matrix to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs",[27,28,29],"Wound, Foot","Diabetic Foot Ulcer (DFU)","Venus Leg Ulcer",[31,32,29,33],"DFU","VLU","Diabetic Foot Ulcer","RECRUITING","2026-07-13",{"date":37,"type":38},"2026-07-14","ACTUAL",{"date":40,"type":38},"2026-06-22",{"date":42,"type":21},"2026-12-20",{"name":44,"class":45},"Capsicure, LLC","NETWORK",7,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100596538","camp-rwe-trial-amnion-grafts-for-healing-hard-to-heal-ulcers-in-rw-populations-100596538","NCT07046767","CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations","A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri- Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs","CAMP RWE","Inclusion Criteria:\n\n1. Male or female 18 years of age and older\n2. 2\\. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of \\>4 weeks duration and visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks\n3. Subjects' wound size is minimum of 2 cm2 and maximum of 25cm2\n4. If the subject has more than one eligible wound the largest wound will be selected (the index wound)\n5. Subject is able and willing to follow the protocol requirements\n6. Subject has signed informed consent\n\nExclusion Criteria:\n\n1. Inability to adhere to the study protocol or study visit schedule\n2. Pregnancy\n3. Child-bearing potential without appropriate contraception\n4. Lactation\n5. Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.\n6. Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)\n7. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety\n8. Known contraindications to the use of amniotic tissue grafts\n9. The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics",{"count":56,"type":21},165,[24],"CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs",[28,60,61],"Venous Leg Ulcer","Wound; Foot",[63,32,33,29],"DCF","2025-10-21",{"date":66,"type":38},"2025-10-22",{"date":68,"type":38},"2025-10-01",{"date":70,"type":21},"2026-07-20",{"name":44,"class":45},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":91,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100458581","examining-the-effectiveness-of-dermgen-in-the-treatment-of-diabetic-foot-ulcers-in-first-nations-people-100458581","NCT05251480","Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People","Examining the Effectiveness of DermGEN™ Versus Standard of Care in the Treatment of Diabetic Foot Ulcers in First Nations People Living in Northwestern Ontario Communities","Inclusion Criteria:\n\n* Participant and social support (e.g., family, caregiver) ready and willing to participate and comply with follow-up regime\n* Participant willing to be involved in self-care (e.g., keep dressing dry at home) required during treatment\n* Participant willing to wear Total Contact Cast (TCC) for wound off-loading during treatment\n* Participant or legal representative has read and signed the informed consent form\n* Documented stable Type I or II diabetes (HbA1C between 5.0 to 10 mmol\u002FL within 1 month prior to Day 0)\n* Ulcer has been present for a minimum of 2 weeks as of Day 0\n* Ulcer area is ≥2 cm2 prior to debridement at Day 0 of study\n* Ulcer extends through dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone or joint capsule\n* Ulcer is free of dead tissue and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting on Day 0\n* Adequate perfusion to the extremity determined by at least one of the following:\n\nPalpable pedal pulses, Transcutaneous oxygen measurement at the dorsum of the foot ≥30 mm Hg, Ankle-brachial index ranging from 0.8 to 1.2, At least biphasic Doppler arterial waveforms at the dorsalis pedis and posterior tibial arteries\n\nExclusion Criteria:\n\n* The individual has any condition that seriously compromises their capacity to provide consent and answers questions related to this study.\n* Untreated infection of soft tissue or bone and\u002For autoimmune connective tissue disorders\n* Ulcer is over Charcot deformity (joints deformity of foot and ankle common in people with diabetes)\n* Body mass index ≥50 kg\u002Fm2\n* Ulcer is not classified as diabetes-related\n* Ulcer has tunnels or sinus tracts that cannot be completely debrided\n* Medical condition(s) that in the investigators' opinion make the patient inappropriate for study (e.g active liver disease)\n* Presence of malignant disease not in remission for 5 years or more\n* The individual is undergoing chemotherapy\u002Fradiation therapy\n* The individual received radiation therapy within 30 days of Day 0 of study\n* The individual is taking an immunosuppressant medication (e.g., corticosteroids, immunosuppression or cytotoxic agents), or is anticipated to require such agents during study\n* Presence of acute or chronic hepatitis, liver disease, anemia, serum albumin \\\u003C2.0 gm\u002FdL, or has alkaline phosphatase or LDH at twice the normal upper limit\n* Obvious clinical signs and symptoms of ongoing tissue infection (i.e., cellulitis) or bone infection (i.e., osteomyelitis)\n* Female individuals are pregnant at time or intend to get pregnant during study time\n* The individual has known allergies to antibiotics, such as penicillin and streptomycin\n* The individual is an active smoker (smoke one or more cigarette a day)\n* The individual has a history of a bleeding disorder or is taking blood thinner medication","80 Years",{"count":81,"type":21},120,[24],"The study will examine the effectiveness of a decellularized dermal matrix (i.e., DermGEN™) in improving wound healing, quality of life and associated costs of treatment of DFUs in First Nations people living in the Northwestern Ontario Communities. First Nations people with active diabetic foot (DFU) ulcer attending a wound care clinic located at the Rainy River district office. An interventional, two-arm, randomized, prospective study of (1) standard of care (control) vs. (2) DermGEN™ - a decellularized dermal matrix (treatment) will be used in the treatment and management of DFU. Patients will be randomized to each arm (n=60 per arm) based on power calculations using data from our Pilot study.",[85,86,87,33,88,89,61,90],"Diabetes Mellitus","Ulcer Foot","Ulcer Healing","Non-healing Wound","Wound of Skin","Tissue Injury",[92,33,88,93,94,95,96,97,98,99],"Diabetic Ulcer","Tissue Engineering","Regenerative Medicine","Decellularized Matrix","Acellular Dermal Matrix","Tissue Allograft","Indigenous Healing","Advanced Wound Care","NOT_YET_RECRUITING","2024-07-02",{"date":103,"type":38},"2024-07-03",{"date":105,"type":21},"2024-12-30",{"date":107,"type":21},"2026-12-01",{"name":109,"class":110},"DeCell Technologies Inc.","INDUSTRY",1,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":5},"100484479","a-clinical-investigation-to-follow-the-progress-of-exuding-chronic-wounds-using-mepilex-up-as-the-primary-dressing-100484479","NCT05588583","A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.","A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up","Inclusion Criteria:\n\n* Signed consent to participate (including consent for digital imaging)\n* Adult aged ≥18 years\n* Diagnosed with a chronic, exuding VLU or DFU\n* Exudate amount moderate to large\n* Wound size from 3 cm2 to 30 cm2 for VLU and ≥1 cm2 for DFU, as determined by the clinician\n* For VLU: ABPI (within 3 months) \\> 0.7. If ABPI \\> 1.4, then big toe pressure \\> 60 mmHg is required or an alternative measurement verifying normal distal arterial flow\n* For VLU: Willing to be compliant with compression therapy\n\nExclusion Criteria:\n\n* Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment\n* Circumferential wound\n* Known allergy\u002Fhypersensitivity to the materials of the dressing\n* Patients participating in the DIPLO NBF study\n* Use of wound fillers",{"count":120,"type":21},68,[24],"The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit.\n\nParticipants will be asked to wear Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.",[124,89,125,61,33,60],"Wounds","Wound Leg",[33,60],"2023-04-18",{"date":129,"type":38},"2023-04-20",{"date":131,"type":38},"2022-10-31",{"date":133,"type":21},"2024-03",{"name":135,"class":110},"Molnlycke Health Care AB"]