[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586682":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":25,"responsibleParty":42,"collaborators":44,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":25,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":25,"enrollmentInfo":55,"targetDuration":25,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":70,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":25},{"fullName":5,"class":6},"NuScience Medical Biologics, LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"No Intervention: Standard of Care","ACTIVE_COMPARATOR","Wound cleansing, Sharps debridement, Dressing for moisture balance, Offloading",[13],"Other: Standard of Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention: NeoThelium FT & Standard of Care","EXPERIMENTAL","Wound cleansing, sharps debridement, NeoThelium FT application, Dressing for moisture balance, Offloading",[19],"Other: NeoThelium FT",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"OTHER","Standard of Care",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"NeoThelium FT","NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.",[15],[31],{"name":32,"affiliation":33,"role":34},"Angelina Ferguson, DNP","SygNola, LLC","STUDY_DIRECTOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","(985) 629-4013","info@sygnola.com",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":39},"Sarah Moore, MBE",{"type":43,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[45],{"name":33,"class":6},"100586682","evaluating-the-efficacy-of-neothelium-ft-in-the-treatment-of-pressure-injuries-100586682",false,"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","ALL","18 Years",{"count":56,"type":57},148,"ESTIMATED","INTERVENTIONAL",[60],"NA","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.",[63],"Pressure Injury",[65,66,67,68,69],"Chronic wounds","Wound Medicine","Cellular, Acellular, Matrix-like Product (CAMP)","Cellular and\u002For Tissue Product (CTP)","Dehydrated Complete Human Placental Membrane (dCHPM)","NOT_YET_RECRUITING","2026-04-06",{"date":73,"type":74},"2026-04-07","ACTUAL",{"date":76,"type":57},"2026-07-01",{"date":78,"type":57},"2028-05-01",{"name":5,"class":6}]