[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610650":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":26,"responsibleParty":45,"collaborators":26,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":26,"enrollmentInfo":57,"targetDuration":26,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":74,"whyStopped":26,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":26},{"fullName":5,"class":6},"Cellution Biologics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","ACTIVE_COMPARATOR","Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first.",[13],"Procedure: Standard of Care (SOC)",{"label":15,"type":16,"description":17,"interventionNames":18},"AIC and Standard of Care","EXPERIMENTAL","Participants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first.",[19,13],"Other: Amnion-Intermediate-Chorion",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"OTHER","Amnion-Intermediate-Chorion","Dehydrated human placental multilayer allograft derived from donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Standard of Care (SOC)","Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.",[15,9],[33],{"name":34,"affiliation":5,"role":35},"Research Director","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Bryanna Finstein","CONTACT","6035574660","bryanna.f@cellutionbiologics.com",{"name":43,"role":39,"phone":40,"phoneExt":26,"email":44},"Cellution Research","clinical@cellutionbiologics.com",{"type":46,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100610650","phase-4-nonhealing-venous-leg-ulcers-treated-with-a-standard-of-care-soc-alone-or-standard-of-care-and-dehydrated-human-placenta-tissue-dhpt-with-crossover-100610650",false,"NCT07230340","Nonhealing Venous Leg Ulcers Treated With a Standard of Care (SoC) Alone or Standard of Care and Dehydrated Human Placenta Tissue (dHPT) With Crossover","A Multicenter, Randomized Trial Evaluating Dehydrated Human Placenta Tissue (dHPT) and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers With Crossover for Subjects Randomized to Standard of Care","EVOLVE","Inclusion Criteria:\n\nParticipants are required to meet all the following criteria for enrollment into the study:\n\n1. 18 years of age or older.\n2. Hemoglobin A1c (HbA1c) level is \\\u003C12% (108 mmol\u002Fmol).\n3. Target ulcer with a surface area of between 1.0 cm 2 and 25.0 cm 2 measured post debridement at randomization.\n4. Target ulcer must have been present for a minimum of 4 weeks with standard of care prior to the initial screening visit.\n5. Affected limb must have adequate perfusion confirmed by vascular assessment performed within 90 days of screening visit. Any of the following methods 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 or triphasic.\n6. If the participant 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.\n7. The participant must agree to attend the weekly study visits required by the protocol.\n8. The participant must be willing and able to participate in the informed consent process\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from enrollment:\n\n1. Known life expectancy of \\\u003C6 months.\n2. Target ulcer is infected or there is cellulitis in the surrounding skin.\n3. Evidence of osteomyelitis complicating the target ulcer.\n4. Participant requires systemic antibiotic therapy or has used within the last 7 days.\n5. Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent), receiving cytotoxic chemotherapy, or taking medications that the investigator believes will interfere with wound healing (e.g., biologics).\n6. Topical application of steroids to the ulcer surface within 30 days of screening.\n7. Target ulcer exposes tendon or bone.\n8. Surface area of the target ulcer decreases by more than 20% during the 2-week screening phase.\n9. Mini Nutritional Assessment (MNA) score of less than 17.\n10. Participants of child bearing potential who are pregnant, considering becoming pregnant within the next 6 months, and\u002For are unwilling to utilize an appropriate form of contraception.\n11. Currently requiring dialysis or planning to start within 6 months.\n12. Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.\n13. Treated with hyperbaric oxygen therapy or a skin substitute within the 30 days prior to screening visit.\n14. Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.\n15. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.","ALL","18 Years",{"count":58,"type":59},70,"ESTIMATED","INTERVENTIONAL",[62],"PHASE4","The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of venous leg ulcers.",[65],"Venous Leg Ulcer (VLU)",[67,68,69,70,71,72,73],"VLU","Venous Ulcer","Leg Wound","Venous Leg Ulcers (VLUs)","Amniotic","Placenta","allograft","NOT_YET_RECRUITING","2025-12-09",{"date":77,"type":78},"2025-12-16","ACTUAL",{"date":80,"type":59},"2026-01",{"date":82,"type":59},"2027-12",{"name":5,"class":6}]