[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07158658":3,"trial-entities:NCT07158658":114,"trial-summary:NCT07158658":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":45,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":64,"locations":67,"central_contacts":100,"overall_officials":108,"references":112,"see_also_links":113},"NCT07158658","NeoPress","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","RECRUITING","2027-01-01","2026-05","2026-05-06","2025-12-01","NuScience Medical Biologics, LLC","INDUSTRY",false,"This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers","This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will begin SOC plus NeoThelium FT weekly applications. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.",[19],"Pressure Injury",[21,22,23,24,25],"Chronic Wounds","Wound Medicine","Cellular and\u002For Tissue Product (CTP)","Dehydrated Complete Human Placental Membrane (dCHPM)","Cellular, Acellular, Matrix-like Product (CAMP)","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},10,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"OTHER","NeoThelium FT (HCT\u002FP 361)","NeoThelium FT (HCT\u002FP 361) is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.",[39],"NeoThelium FT + SOC",[41],{"measure":42,"description":43,"timeFrame":44},"Complete Wound Closure","Complete wound closure (100% epithelialization without drainage)","1-16 weeks",[46,49,53],{"measure":47,"description":48,"timeFrame":44},"Percent Area Reduction","Percent area reduction of wounds at 16 weeks compared to initial baseline measurement (performed using standardized methods of wound area measurement)",{"measure":50,"description":51,"timeFrame":52},"Wound Closure","Evaluate wounds remaining closed for the 2 week follow","2 weeks",{"measure":54,"description":55,"timeFrame":56},"Number of Grafts","Average number of grafts\u002Fweeks used to achieve wound closure","1-12 weeks","ALL","18 Years",null,{"inclusion":61,"exclusion":62,"raw_text":63},[],[],"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",[65,66],"ADULT","OLDER_ADULT",[68,86],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":83},"MedCentris of Bossier City","Bossier City","Louisiana","71111","United States",[75,80],{"name":76,"role":77,"phone":78,"email":79},"Susan Law Law, LPN","CONTACT","318-409-0119","susan.law@medcentris.com",{"name":81,"role":82},"Kendra Halsell, FNP","PRINCIPAL_INVESTIGATOR",{"lat":84,"lon":85},32.51599,-93.73212,{"facility":87,"status":88,"city":89,"state":71,"zip":90,"country":73,"contacts":91,"geoPoint":97},"MedCentris of Rayville","NOT_YET_RECRUITING","Rayville","71269",[92,95],{"name":93,"role":77,"email":94},"Kimberly Lambert","kimberly.lambert@medcentris.com",{"name":96,"role":82},"Reagan Savage, NP",{"lat":98,"lon":99},32.47736,-91.75485,[101,105],{"name":102,"role":77,"phone":103,"email":104},"Angelina Ferguson, DNP","986-629-4013","dr.aferguson@sygnola.com",{"name":106,"role":77,"phone":103,"email":107},"Sarah Moore, MBE","sarah.moore@sygnola.com",[109],{"name":102,"affiliation":110,"role":111},"SygNola, LLC","STUDY_CHAIR",[],[],{"nct_id":4,"conditions":115,"biomarkers":117},[116],"Pressure Sore",[],{"nct_id":4,"found":119,"summary":120,"prompt_version":130},true,{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an open-label study, meaning both you and the researchers will know you are receiving NeoThelium FT. It is a case series, and about 10 people are expected to participate.","completed","NeoThelium FT for Chronic Pressure Ulcers","This study is looking at how well and how safely a product called NeoThelium FT works for people with chronic pressure ulcers (bedsores). NeoThelium FT is a special wound covering made from donated human placental tissue. You might be able to join if you are 18 or older and have a Stage 2 or 3 pressure ulcer on your pelvis or lower leg that is between 1 and 30 square centimeters in size and not infected. The main goal is to see if your wound completely closes within 1 to 16 weeks. This study is currently unclear on its recruitment status and plans to enroll 10 participants.","The study measures complete wound closure between 1 and 16 weeks, indicating follow-up during this period.",107,"If you join, you will receive weekly applications of NeoThelium FT in addition to standard care. You will continue with follow-up visits according to the study schedule.","Not stated in the trial record.",[],"v2"]