[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ulcer-foot\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ulcer-foot":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,50,77,105,133,154,174,204,239,261,284,305,328,355,376,396],{"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":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100639806","nutritional-status-in-adults-with-diabetic-foot-ulcers-100639806",false,"NCT07621770","Nutritional Status in Adults With Diabetic Foot Ulcers","Nutritional Status in Adults With Diabetic Foot in an Outpatient Wound Clinic: A Feasibility and Pilot Study","NutriDFU-P","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosed with diabetes type 1 or type 2\n* Presence of one or more DFUs\n* Receiving treatment in a participating outpatient wound clinic\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Above ankle amputation of the contralateral leg\n* Current treatment with intravenous antibiotics for acute infection.\n* Current hospitalisation for acute surgical management of the foot ulcer\n* Declining or unable to participate in a telephone follow-up interview.\n* Current long-term enteral (tube feeding) or parenteral nutritional support.\n\nExclusion criteria for bioelectrical impedance analysis (BIA)\n\n\\- Presence of a cardiac pacemaker or other implanted electronic device","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","OBSERVATIONAL","This feasibility and pilot study has two aims. The primary aim is to assess the feasibility of collecting clinical, nutritional, and functional data among adults with diabetic foot ulcers (DFUs) who are treated at an outpatient wound clinic. Specifically, the study will evaluate recruitment and inclusion rates, the relevance and clinical utility of selected variables, and assess the completeness and reliability of data collection.\n\nThe secondary aim is to provide a preliminary characterisation of nutritional status, dietary intake, body composition, muscle strength, mobility, and wound-related quality of life, to inform the design and methodology of a future full-scale national study.\n\nDFUs are associated with delayed healing, recurrent infections, reduced quality of life, and increased risk of hospitalization and amputation. These conditions are frequently accompanied by systemic inflammation, impaired circulation, and metabolic disturbances, which may increase nutritional requirements and negatively affect wound healing.\n\nDespite nutrition being recognized as a modifiable factor of ulcer healing, the nutritional status of individuals with DFUs remains insufficiently characterised, and evidence regarding clinically relevant nutritional deficiencies in this population is limited.\n\nParticipants will undergo assessment of height, weight, body composition, handgrip strength, and a 24-hour dietary recall interview during an outpatient clinic visit. Nutritional screening questionnaires and patient-reported measures of appetite, nutritional impact symptoms, mobility, and quality of life will be collected through telephone interviews within one week of the clinical visit.\n\nEligible participants are adults (\\>18 years) who are referred to the outpatient wound clinic with a hard-to-heal foot ulcer. Participants must be able to communicate in Danish or English.",[25,26,27,28,29,30,31],"Diabetic Foot Ulcers (DFU)","Nutrition Assessment","Malnutrition (Calorie)","Ulcer Foot","Dietary Intake Assessment","Bio-Impedance Measurements","Wound Healing",[33,34,35,36,37,38],"DFU","Malnutrition","Wound healing","Nutritional assessment","outpatient","hard-to-heal ulcer","NOT_YET_RECRUITING","2026-05-29",{"date":42,"type":43},"2026-06-02","ACTUAL",{"date":42,"type":21},{"date":46,"type":21},"2026-10-30",{"name":48,"class":49},"Hvidovre University Hospital","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100637318","efficacy-of-a-new-composition-bu002-for-debridement-of-chronic-cutaneous-ulcers-100637318","NCT07607106","Efficacy of a New Composition (BU002) for Debridement of Chronic Cutaneous Ulcers","New Product for the Simple, Rapid, and Effective Debridement of Skin Ulcers","Inclusion Criteria\n\nA pure or mixed venous ulcer, or a diabetic, neuropathic, or neuroischemic foot ulcer, greater than or equal to 4 cm² and less than or equal to 30 cm² with critical colonization.\n\nA duration of the ulcer greater than or equal to 2 months and less than or equal to 2 years.\n\nAge over 60 years: due to the higher prevalence of ulcers in adults over 60 years of age.\n\nAn ankle-brachial index between 0.6 and 1.3.\n\nExclusion criteria\n\nMorbid obesity (BMI \\> 35)\n\nHistory of cancer treatment in the last year\n\nUncontrolled diabetes (Glycated Hemoglobin above 10 mg\u002FdL)\n\nUncontrolled hypertension (blood pressure readings greater than 140\u002F90 mmHg)\n\nPatients with a known allergy to the components of the products under study.\n\nPatients with signs of infection or undergoing antibiotic therapy.","60 Years",{"count":59,"type":21},80,"INTERVENTIONAL",[62],"NA","This study is testing a new liquid treatment for people with long-lasting (chronic) wounds, such as venous leg ulcers or diabetic foot ulcers. These wounds can be difficult to heal because they often contain dead tissue and bacteria. The new product is designed to help clean the wound and remove dead tissue, which may help the wound heal better. It will be compared to a commonly used treatment called Polyhexanide gel.\n\nAbout 80 people aged 60 years or older will take part in this study. Each participant will be randomly assigned (like flipping a coin) to receive either the new treatment or the standard treatment. Neither the participant nor most of the study team will know which treatment is being used during the study to ensure fair results.\n\nThe study will last 4 weeks. Participants will attend eleven visits at the wound care center. During these visits, trained nurses will clean and treat the wound. The study team will:\n\n* Measure the size of the wound\n* Take small samples from the wound to check for bacteria\n* Ask questions about pain and general health\n* Check blood flow in the legs\n* Perform blood tests at the beginning A specialist doctor will examine the wound at the start and at the end of the study to see how it has improved.\n\nOverall, this study aims to find out if the new treatment can help wounds heal better and more quickly than current standard care.\n\nTaking part in the study is completely voluntary. Participants can leave the study at any time without affecting their usual medical care. All personal and medical information will be kept confidential.",[65,28],"Ulcer Venous","RECRUITING","2026-05-19",{"date":69,"type":43},"2026-05-26",{"date":71,"type":43},"2025-10-01",{"date":73,"type":21},"2026-12",{"name":75,"class":49},"Universidad del Desarrollo",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":60,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":76},"100599588","phase-4-randomized-evaluation-of-nonhealing-diabetic-foot-ulcers-with-exclusive-wound-therapy-100599588","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.",{"count":86,"type":21},350,[88],"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.",[91,33,92,93,94,95,28],"Diabetic Foot Ulcer","Diabetic Foot Ulcer (DFU)","Foot Ulcer Due to Type 1 Diabetes Mellitus","Foot Ulcer Due to Type 2 Diabetes Mellitus","Ulcer","2026-05-18",{"date":67,"type":43},{"date":99,"type":43},"2025-07-11",{"date":101,"type":21},"2027-07",{"name":103,"class":104},"Sequence LifeScience, Inc.","INDUSTRY",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":60,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":4},"100627541","modified-platform-trial-assessing-multiple-umbilical-cord-based-camps-and-soc-v-soc-alone-in-the-treatment-of-hard-to-heal-dfus-100627541","NCT07449975","Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal DFUs","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Umbilical CORD-Based Skin Substitutes and Standard of Care Versus Standard of Care Alone in the Treatment of Hard-to-Heal Diabetic Foot Ulcers","CORDSTIM-DFU","Inclusion Criteria:\n\n1. At least 18 years of age or older.\n2. Diagnosis of type 1 or 2 Diabetes mellitus.\n3. At enrollment, 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 MolecuLight® Imaging Device.\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 full thickness without exposed 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: a. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3; b. Toe-Brachial Index (TBI) ≥ 0.6; c. Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg; d. 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 target ulcer 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. 20. The potential subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutrition Assessment.",{"count":114,"type":21},272,[62],"The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products\u002Fskin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.",[92,28,118,119],"Diabetic Foot","Foot Ulcer",[121,122,123],"Cellular, Acellular, Matrix-like Product (CAMP)","Cellular and\u002For Tissue Product (CTP)","Dehydrated Human Umbilical Cord (dHUC)","2026-02-26",{"date":126,"type":43},"2026-03-04",{"date":128,"type":21},"2026-07",{"date":130,"type":21},"2029-09",{"name":132,"class":104},"StimLabs",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":60,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":152,"locationsCount":153},"100550635","modified-platform-trial-assessing-multiple-camps-and-soc-vs-soc-alone-in-the-treatment-of-hard-to-heal-dfus-100550635","NCT06449638","Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Placental-Based Skin Substitutes and Standard of Care Versus SOC Alone in the Treatment of Hard-to-Heal Diabetic Foot Ulcers","CAMPSTIM","Inclusion Criteria:\n\n1. At least 18 years of age or older.\n2. Diagnosis of type 1 or 2 Diabetes mellitus.\n3. At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 25.0 cm2 measured post debridement with the MolecuLight® Imaging Device.\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 full thickness without exposed 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 target ulcer 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 Nutrition Assessment.",{"count":114,"type":21},[62],"The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products\u002Fskin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.",[92,28,118,119],[121,122,146],"Dehydrated Complete Human Placental Membrane (dCHPM)",{"date":148,"type":43},"2026-03-02",{"date":150,"type":43},"2024-07-16",{"date":73,"type":21},{"name":132,"class":104},5,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":60,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":76},"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":161,"type":21},60,[88],"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.",[118,119,28,33,94,93,91],"2026-02-09",{"date":167,"type":43},"2026-02-11",{"date":169,"type":43},"2025-08-26",{"date":171,"type":21},"2027-08",{"name":173,"class":104},"Applied Biologics, LLC",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":60,"phases":183,"briefSummary":184,"conditions":185,"keywords":191,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":76},"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":182,"type":21},50,[88],"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.",[91,186,33,28,187,188,189,190,95],"Foot Ulcer Chronic","Venous Leg Ulcer (VLU)","Venous Leg Ulcer","Venous Ulcer","Leg Ulcers",[192,95,189,193,194,33,91,119,195],"Leg Ulcer","Venous Leg ulcer","VLU","Diabetic foot","2026-02-05",{"date":165,"type":43},{"date":199,"type":43},"2026-01-02",{"date":201,"type":21},"2027-01",{"name":203,"class":104},"BioLab Holdings",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":60,"phases":214,"briefSummary":215,"conditions":216,"keywords":224,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":76},"100525657","early-percutaneous-transluminal-angioplasty-in-diabetic-foot-syndrome-pta-dfs-100525657","NCT06124586","Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)","Role of Percutaneous Transluminal Angioplasty for Wound Healing and Dynamics of the Microbial Community in Patients With Type 2 Diabetes and Diabetic Foot Syndrome","PTA-DFS","Inclusion Criteria:\n\n* volunteer adults\n* written informed consent\n* presence of known manifest T2D and fulfilment of the following criteria:\n* HbA1c \\\u003C 10%\n* presence of pAVD with fulfillment of the following criteria:\n* PAD Stage After Fontaine IV (foot ulcer)\n* Presence of foot ulcer with fulfillment of the following criteria:\n* Foot ulceration without indication for emergency surgical care from stage Wagner 1.\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Acute leg ischemia (sudden onset, sensorimotor deficits, pale extremity, pain, loss of pulse, and shock).\n* Type 1 diabetes mellitus (GADA, ICA, IA-2A, ZnT8A positive).\n* Minors or subjects incapable of giving consent\n* Pregnant or breastfeeding women\n* Treatment with certain drugs (immunosuppressive therapy,\n* Immunomodulators, chemotherapy, antibiotic therapy \\\u003C 2 weeks before\n* intervention)\n* Diseases of the pancreas\n* Severe neurological or psychiatric disease\n* Known presence of malignant tumor disease within the past 5 years\n* Participation in other interventional trials and receipt of investigational medication within the last 30 days\n* Blood or plasma donation within the last 3 months",{"count":213,"type":21},200,[62],"The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in percutaneous transluminal angioplasty (PTA) readiness (\"immediate\" treatment, within 48h) has advantages over the \"standard of care\", i.e., an elective procedure (\"elective PTA\") for the treatment of diabetic foot ulcer (DFU). The primary study endpoint is to investigate the impact of the \"early PTA\" within 48 hours on wound-healing assessed by wound area changes after PTA using a 3D-camera with artificial intelligence (AI)-based wound-analysis-system. The secondary endpoint is the effect of early PTA on the combined occurrence of major adverse limb (MALE) and cardiac events (MACE) over 12 months post-angioplasty using time-to-event analysis. Data will be collected at baseline, 24 hours, 1, 2, 3, 6, and 12 months after PTA. Diabetic kidney disease, distal symmetric polyneuropathy, retinopathy, cardiomyopathy, laboratory analyses, clinical scores, AI-based fundus photography, echocardiography, duplex sonography, and pulse oscillography will be assessed. Explanatory variables for wound healing are wound microbiome changes using whole-genome sequencing and oxygen saturation of the wound environment measured using near-infrared spectroscopy. Altered microbiome composition in ulcers can lead to severe local and systemic infections and complications, including major amputations. Nevertheless, the specific significance of the wound microbiome composition in chronic ischaemic ulcers in type 2 diabetes and the impact of PTA on the wound microbiome in type 2 diabetes is unclear. The exact timing for treating peripheral arterial disease (PAD) by revascularization in DFU after initial diagnosis is unknown and has yet to be fully understood.",[118,217,218,219,220,221,28,222,223],"Diabetes Mellitus","Peripheral Arterial Disease","Diabetic Neuropathies","Diabetic Retinopathy","Anemia","Ulcer Ischemic","Diabetic Polyneuropathy",[225,226,227,228,229],"diabetic foot syndrome","peripheral artery disease","diabetic food ulcers","microbiome","percutaneous transluminal angioplasty","2026-02-03",{"date":232,"type":43},"2026-02-04",{"date":234,"type":43},"2024-02-01",{"date":236,"type":21},"2028-11-01",{"name":238,"class":49},"Heinrich-Heine University, Duesseldorf",{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":60,"phases":248,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":76},"100623029","phase-3-the-prospective-double-blind-multicenter-placebo-controlled-randomized-comparative-clinical-trial-100623029","NCT07391319","The Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Trial","\"Prospective, Double-blind, Multicenter, Placebo-controlled, Randomized, Comparative Clinical Study of the Efficacy and Safety of the Drug Neovasculgen® Lyophilisate for the Preparation of a Solution for Intramuscular Administration 1.2 mg\", Manufacturer Federal State Budgetary Institution \"NMITs of Hematology\" of the Ministry of Health of the Russian Federation, Russia in Patients With Diabetic Foot Syndrome\"","Inclusion Criteria:\n\n1. Male and female patients aged 18 years and above inclusive (at the time of study entry) with neuroischemic form of diabetic foot syndrome.\n2. Type 1 or type 2 diabetes mellitus.\n3. Prolonged non-healing ulcerative defect on the background of standard therapy (at least 1 month), limited to the foot.\n4. Depth of ulcer defect according to Wagner Scale- 1 or 2 degrees.\n5. Oxygen tension in the tissues directly adjacent to the ulcer defect area, from 20 to 45 mm Hg.\n6. Patients with no urgent indications for limb amputation.\n7. Acceptable ankle- brachial index range of 1.3-0.25.\n8. Patient's willingness to comply with the requirements for examination and treatment.\n9. Availability of written informed consent from the patient.\n10. Patient's consent to follow the regimen of unloading the affected area throughout the study (for patients with plantar ulcer location)\n\nExclusion Criteria:\n\n1. Age under 18.\n2. Chronic ischemia of the lower limbs of non-atherosclerotic (other than diabetes mellitus) origin: vasculitis, systemic connective tissue diseases, Buerger's disease, congenital anomalies and vascular injuries, embolism.\n3. Calcaneal localization of the ulcer.\n4. Neuropathic form of diabetic foot syndrome.\n5. Severe neuroosteoarthropathic deformity of the foot or other deformity that has a significant impact on the healing process.\n6. Ischemia, threatening limb loss.\n7. Presence of clinical signs of an infectious process in the ulcer area that is not controlled by the ongoing antibacterial therapy.\n8. Presence of purulent-destructive lesions of the foot (abscess, phlegmon, osteomyelitis, etc.).\n9. Skin changes associated with venous pathology.\n10. Proliferative and terminal stages of diabetic retinopathy.\n11. The level of glycated hemoglobin at the entrance to the study is more than 11%.\n12. Diabetic ketoacidosis or diabetic precoma.\n13. Systemic use of glucocorticosteroids and\u002For other immunosuppressive drugs within the last 30 days before inclusion in the study.\n14. Recent (less than 1 month) surgery or endovascular intervention on the arteries of the lower extremities or recent (less than 1 month) deep vein thrombosis of the lower extremities.\n15. Recent (less than 3 months) cases of acute myocardial infarction, unstable angina, coronary artery bypass grafting or stenting of the coronary arteries, stroke or transient ischemic attacks.\n16. Planned major surgery in the next 6 months.\n17. Severe concomitant disease with life expectancy less than one year.\n18. Infectious diseases, septic conditions, HIV infection.\n19. Diagnosis of cancer within the last 5 years.\n20. Pregnancy, breastfeeding period.\n21. Positive pregnancy test in women of reproductive age.\n22. Alcohol or drug addiction.\n23. Any other disease (including mental) or clinical condition that, in the opinion of the researcher, may affect the patient's ability to participate in the study.",{"count":247,"type":21},144,[249],"PHASE3","The main objective of the study is to evaluate the efficacy and safety of Neovasculgen® in a course dose of 2.4 mg in combination with standard drug therapy in patients with unilateral neuroischemic form of diabetic foot syndrome.",[28,252],"Mellitus Diabetes","2026-01-29",{"date":196,"type":43},{"date":256,"type":43},"2025-02-11",{"date":258,"type":21},"2027-03-31",{"name":260,"class":49},"JSC NextGen",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":60,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":76},"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",{"count":268,"type":21},100,[62],"To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.",[91,217,119,272,95,28,273,274],"Foot Ulcer, Diabetic","Ulcer, Leg","Ankle Ulcer","2025-12-09",{"date":277,"type":43},"2025-12-15",{"date":279,"type":43},"2020-10-13",{"date":281,"type":21},"2026-10-01",{"name":283,"class":49},"University of Minnesota",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":60,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":304,"locationsCount":76},"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":293,"type":21},650,[88],"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.",[118,33,91,272,28,188,192,297,95],"Leg Ulcers Venous","2025-07-24",{"date":300,"type":43},"2025-07-28",{"date":302,"type":43},"2025-07-15",{"date":101,"type":21},{"name":203,"class":104},{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":17,"minAge":312,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":60,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":76},"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.","21 Years",{"count":314,"type":21},340,[88],"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.",[188,318,118,91,272,28,192,65,95],"Venous Leg","2025-02-12",{"date":321,"type":43},"2025-02-13",{"date":323,"type":43},"2024-12-06",{"date":325,"type":21},"2027-12",{"name":327,"class":104},"Tiger Biosciences, LLC.",{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":60,"phases":336,"briefSummary":337,"conditions":338,"keywords":339,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":76},"100558398","dehydrated-human-amnion-membrane-and-standard-of-care-versus-standard-of-care-alone-in-nonhealing-diabetic-foot-ulcers-100558398","NCT06550596","Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers","A Randomized Controlled Multicenter Clinical Trial Evaluating Dehydrated Human Amnion Membrane (dhAM) and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers","Inclusion Criteria:\n\n* Subjects must be at least 18 years of age or older.\n* Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.\n* At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 cm2 measured post debridement.\n* 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.\n* The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.\n* 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.\n* 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.\n* 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.\n* The subject must consent to using the prescribed offloading method for the duration of the study.\n* The subject must agree to attend the weekly study visits required by the protocol.\n* The subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n* A subject known to have a life expectancy of \\\u003C 6 months is excluded.\n* The subject is excluded if the target ulcer is not secondary to diabetes.\n* If the target ulcer is infected or if there is cellulitis in the surrounding skin, the subject is excluded.\n* If there is evidence of osteomyelitis complicating the target ulcer, the subject is excluded.\n* A potential subject cannot have an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n* A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.\n* The topical application of steroids to the ulcer surface within one month of initial screening is not permitted.\n* A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.\n* 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).\n* 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.\n* A subject is excluded if they are malnourished: a score of less than 17 on the Mini Nutritional Assessment (MNA).\n* A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer is excluded.\n* Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.\n* A potential subject with end stage renal disease requiring dialysis is excluded.\n* A subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments is excluded.\n* A Subject treated with hyperbaric oxygen therapy or a Cellular Acellular, or Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit is excluded.",{"count":268,"type":21},[62],"The purpose of this study is to evaluate the efficacy of dehydrated human amnion membrane (dhAM) and standard of care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).",[118,28,119,91],[121,340,341,192,342,343,344,217,219,345,118,119,95],"Dehydrated Human Amnion Membrane (dhAM)","Vascular Diseases","Ulcer leg","Skin Ulcer","Diabetes Complications","Foot Diseases","2025-01-28",{"date":348,"type":43},"2025-01-30",{"date":350,"type":43},"2024-09-23",{"date":352,"type":21},"2025-10",{"name":354,"class":104},"Axolotl Biologix",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":17,"minAge":312,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":60,"phases":364,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":76},"100559159","modified-multi-platform-trial-assessing-multiple-camps-and-soc-vs-soc-alone-in-the-treatment-of-dfu-and-vlus-100559159","NCT06560502","Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs","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 DFUs and VLUs.","Inclusion Criteria:\n\n* 1\\. Subjects must be at least 21 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 5.0 cm2 measured post debridement .\n\n  4\\. 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.\n\n  5\\. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.\n\n  6\\. 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.\n\n  7\\. 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  a. ABI between 0.7 and ≤ 1.3; b. TBI ≥ 0.6; c. TCOM ≥ 40 mmHg; d. PVR: biphasic. 8. 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\n  9\\. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.\n\n  10\\. The potential subject must consent to using the prescribed offloading method for the duration of the study.\n\n  11\\. The potential subject must agree to attend the weekly study visits required by the protocol.\n\n  12\\. 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, requires systemic antibiotic therapy, 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. 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).\n7. The potential subject is taking hydroxyurea .\n8. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n9. 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.\n10. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n11. 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).\n12. The surface area measurement of the 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.\n13. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n14. Women who are pregnant or considering becoming pregnant within the next 6 months.",{"count":363,"type":21},324,[62],"This is 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.",[91,188,28,192],"2025-01-16",{"date":369,"type":43},"2025-01-20",{"date":371,"type":43},"2024-08-01",{"date":373,"type":21},"2026-08",{"name":375,"class":104},"Stability Biologics",{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":60,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":76},"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":384,"type":21},124,[62],"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",[91,118,119,28,33],"2024-11-18",{"date":390,"type":43},"2024-11-20",{"date":392,"type":43},"2024-09-20",{"date":394,"type":21},"2025-08",{"name":173,"class":104},{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":60,"phases":406,"briefSummary":407,"conditions":408,"keywords":414,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":76},"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":405,"type":21},120,[62],"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.",[217,28,409,91,410,411,412,413],"Ulcer Healing","Non-healing Wound","Wound of Skin","Wound; Foot","Tissue Injury",[415,91,410,416,417,418,419,420,421,422],"Diabetic Ulcer","Tissue Engineering","Regenerative Medicine","Decellularized Matrix","Acellular Dermal Matrix","Tissue Allograft","Indigenous Healing","Advanced Wound Care","2024-07-02",{"date":425,"type":43},"2024-07-03",{"date":427,"type":21},"2024-12-30",{"date":429,"type":21},"2026-12-01",{"name":431,"class":104},"DeCell Technologies Inc."]