[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"LifeNet Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":102},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100601928","matrion-decellularized-placental-membrane-versus-conventional-wound-management-in-subjects-with-diabetic-foot-ulcers-100601928",false,"NCT07116876","Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers","An Open-Label Trial to Assess the Clinical Effectiveness of Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers","Inclusion Criteria:\n\nTo be considered eligible to participate in this study, a subject must meet the inclusion criteria listed below:\n\n1. Be male or female and aged between 21 and 80 years at the time of informed consent\n2. Have a diagnosis of Type I or Type II diabetes as defined by the American Diabetes Association and have been on a stable anti-diabetic treatment regimen for at least 30 days before the baseline visit.\n3. Have full-thickness wound of the lower extremity, below the ankle\n4. Have a single target ulcer\n5. Have a wound with an area greater than or equal to 1cm2 and less than 25 cm2 with a depth less than or equal to 9 mm\n6. Have a diabetic foot ulcer that has been present for at least 30 days with a Wagner Classification Grade 1 or 2:\n\n   * Grade 1: superficial diabetic ulcer involving the full skin thickness but not underlying tissues\n   * Grade 2: ulcer extension involving ligament, tendon, joint capsule, or fascia, without presence of abscess or osteomyelitis\n7. Have an absence of infection based on Infectious Disease Society of America criteria (assessed at BOTH Screening\u002FVisit 1 and Baseline\u002FVisit 2)\n8. Have an adequate circulation to the affected lower extremity, defined as at least one of the criteria within the previous 60 days:\n\n   * Transcutaneous oxygen measurement at the dorsum of the foot greater or equal to 30 mm Hg\n   * Ankle-brachial index (ABI) ranging from 0.8 to 1.2\n   * At least biphasic Doppler arterial waveforms at the dorsalis pedis and posterior tibial arteries\n9. Have the ability to comply with off-loading and dressing change requirements\n10. Have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and agree to abide by the study restrictions and return to the site for the required assessments\n11. Have provided written authorization for use and disclosure of protected health information\n12. Have a life expectancy of greater than 6 months\n\nExclusion Criteria:\n\nTo be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:\n\n1. Be pregnant or lactating\n2. Subjects with a target wound \\\u003C30 days old at Screening whose wound area has decreased in size ≥50% between the Screening and Baseline Visits (assessed at Baseline\u002FVisit 2)\n3. Have a circulating hemoglobin A1c exceeding 12% within 90 days of the Screening Visit (assessed at Screening\u002FVisit 1 for subjects with labs collected \\\u003C30 days of screening; assessed at Baseline\u002FVisit 2 for subjects with labs collected at screening)\n4. Have a serum creatinine concentration of 3.0 mg\u002FdL or greater within 30 days prior to screening (assessed at Screening\u002FVisit 1 for subjects with labs collected \\\u003C30 days of screening; assessed at Baseline\u002FVisit 2 for subjects with labs collected at screening)\n5. Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin\n6. Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol\n7. Have the wound treated with biomedical or topical growth factors within the previous 30 days before the Screening Visit\n8. Need for any additional concomitant dressing material other than the ones approved for this study\n9. Have clinical signs of an infection at the study ulcer site (assessed at BOTH Screening\u002FVisit 1 and Baseline\u002FVisit 2)\n10. Have the inability to tolerate an off-loading boot\n11. Have a known or suspected disease of the immune system\n12. Have an active or untreated malignancy or active, uncontrolled connective tissue disease\n13. Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the Baseline Visit\n14. Have presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement (assessed at Baseline\u002FVisit 2)\n15. Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the Baseline Visit\n16. Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening (assessed at Screening\u002FVisit 1 if subject had labs collected \\\u003C30 days of screening; assessed at Baseline\u002FVisit 2 if subject had labs collected at screening)\n17. Have active Charcot disease\n18. Have undergone treatment with a living skin equivalent within the last 4 weeks before screening\n19. Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot\n20. Have the presence of any condition that in the opinion of the investigator places the subject at undue risk or potentially jeopardizes the quality of the data to be generated","ALL","21 Years","80 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study will evaluate Matrion™ (LifeNet Health, Inc., Virginia Beach, VA), a placental membrane product, as a treatment for diabetic foot ulcers compared to conventional wound care. Matrion is derived from donated human birth tissue and includes both the amniotic and chorionic layers, along with the trophoblast layer. It is minimally processed using a proprietary decellularization method and terminally sterilized to ensure the membrane is acellular and sterile, making it suitable for surgical applications.",[27,28],"Diabetic Foot Ulcer (DFU)","Lower Extremity",[30,31,32,33,34,35,36],"diabetic foot ulcer","placental membrane","lower extremity wound","decellularized placental membrane","foot diseases","foot ulcer","conventional wound management","RECRUITING","2025-12-09",{"date":40,"type":41},"2025-12-10","ACTUAL",{"date":43,"type":41},"2025-06-26",{"date":45,"type":21},"2026-06",{"name":47,"class":48},"LifeNet Health","INDUSTRY",18,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":60,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100506911","decellularized-femoral-artery-allograft-nexeon-avx-prospective-registry-100506911","NCT05880537","Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry","Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft for Arteriovenous Access for Hemodialysis: A Multi-center Prospective Registry Study","Inclusion Criteria:\n\n1. Be male or female, ≥18 years of age at the time of graft placement\n2. Have a diagnosis of ESRD or renal dysfunction requiring hemodialysis\n3. Subject requires dialysis access to start or maintain dialysis treatment and placement of an AV access graft is a viable access option.\n4. Have the ability themselves, or through their legal guardian, to understand the requirements of the study, to provide written informed consent\u002Fassent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and to agree to abide by the study restrictions and return to the site for the required assessments\n5. Have provided written authorization for use and disclosure of protected health information\n\nExclusion Criteria:\n\n1. Be participating in a study of another investigational drug or device\n2. Have a known sensitivity to any of the processing reagents utilized in the manufacture of this product such as antibiotics (Lincomycin, Polymyxin B, Ciprofloxacin, Meropenum, Gentamicin, or Vancomycin) and processing reagents (N-lauroyl sarcosine, Denarase and glycerol\u002Fglycerin)\n3. Have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment\n4. Have a history or evidence of severe peripheral vascular disease in the upper extremities\n5. Have the inability or be unable or unwilling to follow the study visit schedule\n6. Have the presence of any condition that, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated","18 Years",{"count":59,"type":21},100,"24 Months","OBSERVATIONAL","Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,",[64],"End-Stage Renal Disease","2025-03-28",{"date":67,"type":41},"2025-04-02",{"date":69,"type":41},"2023-06-06",{"date":71,"type":21},"2027-12-15",{"name":47,"class":48},4,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":81,"targetDuration":60,"studyType":61,"phases":4,"briefSummary":83,"conditions":84,"keywords":92,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":73},"100385462","safety-efficacy--use-of-vivigen-cellular-bone-matrix-allograft-in-orthopaedic-fracture-care-100385462","NCT04299022","Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care","Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care: A Multi-Center Prospective Registry and Retrospective Data Collection Study","Prospective Cohort Inclusion Criteria:\n\n* Any skeletally mature patient treated with Vivigen bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will be eligible for inclusion.\n\nRetrospective Cohort Inclusion Criteria:\n\n\\- Any skeletally mature patient treated with adjunct bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will eligible for inclusion.\n\nProspective Cohort Exclusion Criteria:\n\n1. Patients unable to understand either an English or Spanish consent will be excluded.\n2. Patients unable to consent secondary to dementia and\u002For other mental\u002Fpsychiatric diagnoses will be excluded.",{"count":82,"type":21},250,"Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.",[85,86,87,88,89,90,91],"Fractures, Bone","Nonunion of Fracture","Fractures, Open","Fractures, Ununited","Fracture, Tibial","Fracture of Femur","Fracture Arm",[93,94,95],"fracture","nonunion","allograft",{"date":67,"type":41},{"date":98,"type":41},"2021-06-01",{"date":100,"type":21},"2026-07-31",{"name":47,"class":48},""]