[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NuScience Medical Biologics, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":190},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,68,87,110,128,150,168],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100618764","evaluation-of-the-efficacy-of-hyalomatrix-in-the-healing-of-chronic-venous-leg-ulcers-100618764",false,"NCT07335861","Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers","Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers: A Randomized Controlled Multicenter Crossover Trial","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound\n3. Subject has a venous leg ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC\n4. Subject has a venous leg ulcer with a historical wound measurement showing less than 25% healing within 14 days prior to screening\n5. Subject has a venous leg ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization\n6. Subject has a venous leg ulcer without infection or clinically visible exposed bone\n7. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit\n8. Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.\n9. Venous Leg Ulcer is being treated with compression therapy for 14 days prior to treatment visit 1\n10. Index wound is free of necrotic debris prior to Hyalomatrix application\n11. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n12. Index wound is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.\n13. Subject is able and willing to follow the protocol requirements\n14. Subject had signed informed consent\n15. If 2 or more wounds are present, the wounds must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject does not have a diagnosis of venous leg ulcer or venous insufficiency with a wound located on the lower extremity\n2. Subject has a known life expectancy of \\\u003C1 year\n3. Subject is unable to comply with protocol treatment\n4. Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders\n5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n7. Known contraindications to tissue-engineered allograft\n8. Concurrent participation in alternative clinical trial that involves investigational drug or HCT\u002FP interfering with wound treatment and\u002For healing.\n9. Subject is pregnant or breastfeeding\n10. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the wound surface for \\>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study\n11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization\n12. Venous leg ulcer with active infection\n13. Wound depth with visible exposed bone\n14. HBOT within 14 days prior to randomization\n15. Revascularization surgery on the index wound leg within 30 days of screening phase\n16. Index wound suspicious of neoplasm in the opinion of the principal investigator","ALL","18 Years",{"count":19,"type":20},122,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a randomized controlled trial evaluating the efficacy of HYALOMATRIX in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.",[26,27],"Venous Leg Ulcer","Chronic Wounds","RECRUITING","2026-06-26",{"date":31,"type":32},"2026-06-30","ACTUAL",{"date":34,"type":32},"2026-05-14",{"date":36,"type":20},"2027-01-31",{"name":38,"class":39},"NuScience Medical Biologics, LLC","INDUSTRY",4,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":5},"100588229","evaluating-the-efficacy-neothelium-ft-in-the-treatment-of-diabetic-foot-ulcers-100588229","NCT06938685","Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers","Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Diabetic Foot Ulcers: A Randomized Controlled Multicenter Crossover Trial","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and\u002For insulin replacement therapy\n3. Subject has a diabetic foot ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC\n4. Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening\n5. Subject has a diabetic foot ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization\n6. Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior to screening.\n7. Index ulcer is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit\n8. Diabetic foot ulcer is being treated with offloading therapy for 14 days prior to randomization\n9. Adequate circulation of ulcer demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.\n10. Index ulcer is free of infection prior to randomization and during screening phase. Infection must be adequately treated and controlled as defined by Infectious Disease Society of America (IDSA) Guidelines PEDIS Grade 1.\n11. Index ulcer is free of necrotic debris prior to NeoThelium FT application\n12. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n13. Subject is able and willing to follow the protocol requirements\n14. Subject had signed informed consent\n15. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject has a known life expectance of \\\u003C1 year\n2. Subject is unable to comply with protocol treatment\n3. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing\n4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n6. Known contraindications to tissue-engineered allograft\n7. Concurrent participation in alternative clinical trial that involves investigational drug or device interfering with wound treatment and\u002For healing\n8. Subject is pregnant or breastfeeding\n9. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study\n10. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization\n11. Diabetic foot ulcer of Wagner 3 grade with active acute infection that has not completed IV antibiotic treatment, or Wagner 3 grade with chronic refractory osteomyelitis\n12. Wound depth with visible exposed bone\n13. HBOT within 14 days prior to randomization\n14. Revascularization surgery on the index ulcer leg within 30 days of screening phase\n15. Index ulcer suspicious of neoplasm in the opinion of the principal investigator",{"count":49,"type":20},132,[23],"This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot ulcers.",[53],"Diabetic Foot Ulcer",[55,56,57,58,59],"Chronic wounds","Wound Medicine","Cellular, Acellular, Matrix-like Product (CAMP)","Cellular and\u002For Tissue Product (CTP)","Dehydrated Complete Human Placental Membrane (dCHPM)","2026-06-15",{"date":62,"type":32},"2026-06-17",{"date":64,"type":32},"2025-10-06",{"date":66,"type":20},"2026-10-01",{"name":38,"class":39},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":85,"locationsCount":86},"100586683","evaluating-the-efficacy-of-neothelium-ft-in-the-treatment-of-chronic-open-wounds-100586683","NCT06918561","Evaluating the Efficacy of NeoThelium FT in the Treatment of Chronic Open Wounds","A Randomized Controlled Multisite Crossover Trial Evaluating the Efficacy of NeoThelium FT in the Treatment of \"Other\" Open Wounds","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of \"other\" Open wound\n3. Subject has a chronic open wound present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC\n4. Subject has a chronic open wound with a historical wound measurement showing less than 25% healing within 14 days prior to screening\n5. Subject has a chronic open wound with screening wound measurement showing less than 25% healing within 14 days prior to randomization\n6. Subject has an Open wound without infection or clinically visible exposed bone\n7. Index wound is a minimum of 0.5cm2 and a maximum of 25cm2 at first treatment visit\n8. Index ulcer has a maximum depth of 1cm at screening visit 1\n9. The chronic open wound is treated with offloading therapy, if applicable to location, while standing, sitting, and lying down for 14 days prior to randomization\n10. Adequate circulation of wounds located below the knee demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to randomization OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to randomization.\n11. Index ulcer is free of infection prior to randomization and during screening phase.\n12. Index ulcer is free of necrotic debris prior to NeoThelium FT application\n13. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n14. Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.\n15. Subject is able and willing to follow the protocol requirements\n16. Subject had signed informed consent\n17. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject with a wound diagnosis of diabetic foot wound, pressure wound, venous leg wound, burn wound, or alternative diagnosis other than \"open wound\"\n2. Subject has a known life expectancy of \\\u003C1 year\n3. Subject is unable to comply with protocol treatment\n4. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing.\n5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n7. Known contraindications to tissue-engineered allograft\n8. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and\u002For healing\n9. Subject is pregnant or breastfeeding\n10. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the wound surface for \\>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study\n11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization\n12. Open wound with active infection\n13. Wound depth with visible exposed bone\n14. HBOT within 14 days prior to randomization\n15. Revascularization surgery on the index wound leg within 30 days of screening phase\n16. Index wound suspicious of neoplasm in the opinion of the principal investigator",{"count":49,"type":20},[23],"This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating chronic open wounds.",[79],"Open Wound",[55,56,57,58,59],{"date":62,"type":32},{"date":83,"type":32},"2025-10-16",{"date":66,"type":20},{"name":38,"class":39},14,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100605141","prospective-case-series-evaluating-the-efficacy-and-safety-of-neothelium-ft-for-chronic-pressure-ulcers-100605141","NCT07158658","Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers","Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Pressure Ulcers: A Prospective Case Series","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of Pressure Injury\u002FUlcer located on the pelvis or lower extremity\n3. Subject has a Pressure Injury\u002FUlcer Stage 2 or 3 without infection\n4. Index ulcer is a minimum of 1cm2 and a maximum of 30cm2 at first treatment visit\n5. Index ulcer has a depth of ≤ 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg, at the providers discretion\n6. Index ulcer has a depth of \\> 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg\n7. Pressure Injury\u002FUlcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 7 days prior to the first treatment visit\n8. Adequate circulation of ulcer, if located on the lower extremity, demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to the first treatment visit\n9. Index ulcer is free of infection prior to the first treatment visit and during screening phase.\n10. Index ulcer is free of necrotic debris prior to NeoThelium FT application\n11. Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit\n12. Subject is able and willing to follow the protocol requirements\n13. Subject had signed informed consent\n14. If 2 or more ulcers are present, the ulcers must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject has a known life expectancy of \\\u003C1 year\n2. Subject is unable to comply with protocol treatment\n3. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing in the opinion of the investigator\n4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n6. Known contraindications to tissue-engineered allograft\n7. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and\u002For healing\n8. Subject is pregnant or breastfeeding\n9. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>14 days duration within 30 days prior to the first treatment visit; or anticipated use of the above during the course of the study\n10. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to the first treatment visit\n11. Pressure Injury\u002FUlcer of Stage 4 or active osteomyelitis\n12. Wound depth with visible exposed bone\n13. HBOT within 14 days prior to the first treatment visit\n14. Revascularization surgery on the index ulcer leg within 30 days of screening phase\n15. Index ulcer suspicious of neoplasm in the opinion of the investigator",{"count":95,"type":20},10,[23],"This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers",[99],"Pressure Injury",[27,56,58,59,57],"2026-05-05",{"date":103,"type":32},"2026-05-06",{"date":105,"type":32},"2025-12-01",{"date":107,"type":20},"2027-01-01",{"name":38,"class":39},2,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":109},"100597678","prospective-case-series-evaluating-the-efficacy-and-safety-of-neothelium-ft-for-venous-leg-ulcers-100597678","NCT07061613","Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers","Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Venous Leg Ulcers: A Prospective Case Series","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound\n3. Subject has an venous leg ulcer without infection or clinically visible exposed bone\n4. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit\n5. Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.\n6. Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1\n7. Index wound is free of necrotic debris prior to NeoThelium FT application\n8. Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit\n9. Wound free of clinical signs\u002Fsymptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and prior to the first treatment visit.\n10. Subject is able and willing to follow the protocol requirements\n11. Subject had signed informed consent\n12. If 2 or more wounds are present, the wounds must be separated by at least 2 cm\n\nExclusion Criteria:\n\n1. Subject is unable to comply with protocol treatment\n2. Presence of infection prior to screening.\n3. Multiple VLUs on the same leg with \\\u003C 2 cm separation from the target ulcer.\n4. Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders\n5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.\n6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n7. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.\n8. Concurrent participation in alternative clinical trial that involves investigational drug or HCT\u002FP interfering with wound treatment and\u002For healing.\n9. Subject is pregnant or breastfeeding\n10. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>2 weeks duration within 30 days prior to the first treatment visit; or anticipated use of the above during the course of the study\n11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment\n12. Index ulcer suspicious of neoplasm in the opinion of the principal investigator",{"count":95,"type":20},[23],"This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers",[26],[27,57,58,59],{"date":103,"type":32},{"date":124,"type":32},"2025-09-02",{"date":126,"type":20},"2026-07-29",{"name":38,"class":39},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":4},"100586682","evaluating-the-efficacy-of-neothelium-ft-in-the-treatment-of-pressure-injuries-100586682","NCT06918548","Evaluating the Efficacy of NeoThelium FT in the Treatment of Pressure Injuries","Evaluation of the Efficacy of NeoThelium FT in the Healing of Chronic Pressure Ulcers: A Randomized Controlled Multicenter Trial","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of Pressure Injury\u002FUlcer located on the pelvis or lower extremity\n3. Subject has a Pressure Injury\u002FUlcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC\n4. Subject has a Pressure Injury\u002FUlcer with a historical wound measurement showing less than 50% healing within 30 days prior to randomization\n5. Subject has a Pressure Injury\u002FUlcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization\n6. Subject has a Pressure Injury\u002FUlcer Stage 2, 3, and 4 without infection or clinically visible exposed bone\n7. Index ulcer is a minimum of 1cm2 and a maximum of 25cm2 at first treatment visit\n8. Index ulcer has a maximum depth of 1cm at first screening visit\n9. Pressure Injury\u002FUlcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 14 days prior to randomization\n10. Adequate circulation of ulcer demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to randomization\n11. Index ulcer is free of infection prior to randomization and during screening phase.\n12. Index ulcer is free of necrotic debris prior to \\[insert product\u002Fdevice\\] application\n13. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n14. Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.\n15. Having a Mini Nutritional Assessment Score of 12 or higher indicated a normal nutritional status\n16. Subject is able and willing to follow the protocol requirements\n17. Subject had signed informed consent\n18. If 2 or more ulcers are present, the ulcers must be separated by at least 1 cm\n\nExclusion Criteria:\n\n1. Subject has a known life expectancy of \\\u003C1 year\n2. Subject is unable to comply with protocol treatment\n3. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing\n4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n6. Known contraindications to tissue-engineered allograft\n7. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and\u002For healing\n8. Wound reduces in area by ≥25% after 14 days of SOC prior to randomization\n9. Subject is pregnant or breastfeeding\n10. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study\n11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization\n12. Pressure Injury\u002FUlcer of Stage 4 grade with active osteomyelitis or exposed visible bone\n13. Wound depth with visible exposed bone\n14. HBOT within 14 days prior to randomization\n15. Revascularization surgery on the index ulcer leg within 30 days of screening phase\n16. Index ulcer suspicious of neoplasm in the opinion of the principal investigator",{"count":136,"type":20},148,[23],"This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating pressure injuries.",[99],[55,56,57,58,59],"NOT_YET_RECRUITING","2026-04-06",{"date":144,"type":32},"2026-04-07",{"date":146,"type":20},"2026-07-01",{"date":148,"type":20},"2028-05-01",{"name":38,"class":39},{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":165,"leadSponsor":167,"locationsCount":4},"100587621","evaluating-the-efficacy-of-neothelium-ft-in-the-treatment-of-venous-leg-ulcers-100587621","NCT06930768","Evaluating the Efficacy of NeoThelium FT in the Treatment of Venous Leg Ulcers","Evaluation of the Efficacy of NeoThelium FT in the Healing of Venous Leg Ulcers: A Randomized Controlled Multicenter Trial","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of Venous Insufficiency with an open wound to the lower extremity\n3. Subject has a Venous Leg Ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC\n4. Subject has a Venous Leg Ulcer with a historical wound measurement showing less than 50% healing in 30 days prior to randomization\n5. Subject has a Venous Leg Ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization\n6. Subject has a Venous Leg Ulcer Wagner 1, 2, and 3 without infection or clinically visible exposed bone\n7. Index ulcer is a minimum of 1cm2 and a maximum of 40cm2 at first treatment visit\n8. Venous Leg Ulcer is being treated with compression therapy for 14 days prior to randomization\n9. Adequate circulation of ulcer demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to randomization\n10. Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.\n11. Index ulcer is free of necrotic debris prior to NeoThelium FT application\n12. Female subjects of childbearing potential having a negative pregnancy test prior to randomization\n13. Subject is able and willing to follow the protocol requirements\n14. Subject had signed informed consent\n15. If 2 or more ulcers are present, the ulcers must be separated by at least 1 cm\n\nExclusion Criteria:\n\n1. Subject has a known life expectancy of \\\u003C1 year\n2. Subject is unable to comply with protocol treatment\n3. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing\n4. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound\n5. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n6. Known contraindications to tissue-engineered allograft\n7. Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and\u002For healing\n8. Wound reduces in area by ≥25% after 14 days of SOC prior to randomization\n9. Subject is pregnant or breastfeeding\n10. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>2 weeks duration within 30 days prior to randomization; or anticipated use of the above during the course of the study\n11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to randomization\n12. Venous Leg Ulcer with active infection\n13. Wound depth with visible exposed bone\n14. HBOT within 14 days prior to randomization\n15. Revascularization surgery on the index ulcer leg within 30 days of screening phase\n16. Index ulcer suspicious of neoplasm in the opinion of the principal investigator",{"count":49,"type":20},[23],"This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.",[26],[55,56,57,58,59],{"date":163,"type":32},"2026-04-13",{"date":146,"type":20},{"date":166,"type":20},"2027-06-01",{"name":38,"class":39},{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":21,"phases":176,"briefSummary":177,"conditions":178,"keywords":179,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},"100595972","prospective-case-series-evaluating-the-efficacy-and-safety-of-neothelium-ft-for-diabetic-foot-ulcers-100595972","NCT07039396","Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers","Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Diabetic Foot Ulcers: A Prospective Case Series","Inclusion Criteria:\n\n1. Male or Female, 18 years of age or older\n2. Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and\u002For insulin replacement therapy with a diabetic foot ulcer\n3. Subject has a diabetic foot ulcer of Wagner grade 1, 2, or 3 without infection or clinically visible exposed bone. Wagner 3 is acceptable if the diagnosis is acute osteomyelitis and the subject has successfully completed IV antibiotic treatment prior to screening.\n4. Ulcer area is a minimum of 0.5 cm2 and a maximum of 25 cm2 at first treatment visit\n5. Subject is able and willing to follow the protocol requirements\n6. Subject had signed informed consent\n7. Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \\>0.7 and \\\u003C1.3, or TBI of \\>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit.\n8. Diabetic foot ulcer is being treated with TCC offloading therapy OR Fixed Ankle Walker if approved by Medical Monitor for 7 days prior to treatment visit 1\n9. Wound free of clinical infection (no purulent discharge, cellulitis, or osteomyelitis) post-debridement.\n10. Record of serum hemoglobin A1c within 90 days prior to the first treatment visit\n\nExclusion Criteria:\n\n1. Subject is unable to comply with protocol treatment\n2. Target ulcer is a Wagner 3 of acute osteomyelitis that has not been successfully treated with 6 weeks of IV antibiotics or is diagnosed as chronic refractory osteomyelitis.\n3. Wagner 3, 4, or 5 involving tendon, bone, or joint.\n4. Presence of systemic infection, sepsis, or osteomyelitis at screening.\n5. Multiple DFUs on the same foot with \\\u003C 2 cm separation from the target ulcer.\n6. Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing.\n7. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.\n8. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator\n9. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.\n10. Concurrent participation in alternative clinical trial that involves investigational drug or HCT\u002FP interfering with wound treatment and\u002For healing.\n11. Subject is pregnant or breastfeeding\n12. Subject with history of immunosuppressant treatment (systemic corticosteroids \\>10mg daily dose), cytotoxic chemotherapy, or topical steroid application to the ulcer surface for \\>2 weeks duration within 30 days prior to the first treatment visit; or anticipated use of the above during the course of the study\n13. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment\n14. Index ulcer suspicious of neoplasm in the opinion of the principal investigator",{"count":95,"type":20},[23],"This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers",[53],[27,180,58,59],"Cellular, Acellular, Matrix-like product (CAMP)","2026-03-10",{"date":183,"type":32},"2026-03-12",{"date":185,"type":32},"2025-08-26",{"date":187,"type":20},"2026-06-01",{"name":38,"class":39},3,""]