[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07039396":3,"trial-entities:NCT07039396":125,"trial-summary:NCT07039396":129},{"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":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":44,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":112,"overall_officials":119,"references":123,"see_also_links":124},"NCT07039396","NeoDia","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","RECRUITING","2026-06-01","2026-03","2026-03-12","2025-08-26","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 Diabetic Foot 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],"Diabetic Foot Ulcer",[21,22,23,24],"Chronic Wounds","Cellular, Acellular, Matrix-like product (CAMP)","Cellular and\u002For Tissue Product (CTP)","Dehydrated Complete Human Placental Membrane (dCHPM)","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},10,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"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.",[38],"NeoThelium FT + SOC",[40],{"measure":41,"description":42,"timeFrame":43},"Complete wound closure","The primary endpoint will be the percentage of target ulcers that achieve complete wound closure by manual measurement utilizing a ruler.","1-12 weeks",[45,48,52,55],{"measure":46,"description":47,"timeFrame":43},"Percentage Wound Area Change","The percentage change in wound area from TV-1 to TV-13 will be measured weekly using standardized method of wound area measurement and physical examination.",{"measure":49,"description":50,"timeFrame":51},"Follow-Up Closure","Number of wounds remaining closed during the 2-week follow-up","2 weeks",{"measure":53,"description":54,"timeFrame":43},"Time to Closure","Average number of grafts\u002Fweeks used to achieve wound closure",{"measure":56,"description":57,"timeFrame":58},"Hemoglobin A1c","Average Sample of HbA1c","1 week","ALL","18 Years",null,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"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",[67,68],"ADULT","OLDER_ADULT",[70,88,102],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":85},"MedCentris of Alexandria","Alexandria","Louisiana","71301","United States",[77,82],{"name":78,"role":79,"phone":80,"email":81},"Laura Whittington, LPN","CONTACT","318-545-0655","Laura.whittington@medcentris.com",{"name":83,"role":84},"Rachel Ward, FNP","PRINCIPAL_INVESTIGATOR",{"lat":86,"lon":87},31.31129,-92.44514,{"facility":89,"status":8,"city":90,"state":73,"zip":91,"country":75,"contacts":92,"geoPoint":99},"MedCentris of Leesville","Leesville","71446",[93,97],{"name":94,"role":79,"phone":95,"email":96},"Brandi Shuff, LPN","337-282-1091","Brandi.shuff@medcentris.com",{"name":98,"role":84},"Stefanie Corley, FNP",{"lat":100,"lon":101},31.14352,-93.261,{"facility":103,"status":8,"city":104,"state":73,"zip":105,"country":75,"contacts":106,"geoPoint":109},"MedCentris of Many","Many","71449",[107,108],{"name":94,"role":79,"phone":95,"email":96},{"name":98,"role":84},{"lat":110,"lon":111},31.56878,-93.48406,[113,117],{"name":114,"role":79,"phone":115,"email":116},"Angelina Ferguson, DNP","986-629-4013","info@sygnola.com",{"name":118,"role":79,"phone":115,"email":116},"Sarah Moore, MBE",[120],{"name":114,"affiliation":121,"role":122},"SygNola, LLC","STUDY_CHAIR",[],[],{"nct_id":4,"conditions":126,"biomarkers":128},[127],"Diabetic foot ulcer",[],{"nct_id":4,"found":130,"summary":131,"prompt_version":141},true,{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is a case series study where both you and the researchers will know which treatment you are receiving (open-label). About 10 participants are planned for this study.","completed","NeoThelium FT for Diabetic Foot Ulcers","This study is testing a product called NeoThelium FT (HCT\u002FP 361) to see how well it works and if it's safe for people with diabetic foot ulcers. NeoThelium FT is a wound covering made from donated human placental tissue. The study is looking for about 10 adults, aged 18 or older, who have type 1 or type 2 diabetes and a diabetic foot ulcer that isn't infected and doesn't have exposed bone. The main goal is to see if the ulcers completely close within 1 to 12 weeks. The study's current status is unclear, so we don't know if they are actively recruiting participants right now.","The study will follow your wound closure for 1 to 12 weeks.",106,"If you join, you will receive weekly applications of NeoThelium FT in addition to standard care. You will continue to have follow-up appointments according to the original schedule.","Not stated in the trial record.",[35],"v2"]