The study is designed to test the effectiveness and safety of a new skin graft product called NeoThelium FT for treating venous leg ulcers. Venous leg ulcers are open sores on the leg caused by poor blood flow, and they can be difficult to heal. This research is important as it aims to improve healing outcomes for patients with these ulcers, potentially making treatment more effective and helping insurance companies decide on coverage. The study takes place in several medical centers and involves participants who have agreed to join and meet specific criteria. Participants in the study will receive their standard care plus weekly applications of the NeoThelium FT skin graft. Both the researchers and the participants know which treatment is given, which is known as an open label study. The participants will follow a schedule for check-ups to monitor their progress. The study aims to collect data on how well the treatment works and if it helps with insurance reimbursement decisions. This information could lead to better treatment strategies for those suffering from venous leg ulcers.
Inclusion Criteria: 1. Male or Female, 18 years of age or older 2. Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound 3. Subject has an venous leg ulcer without infection or clinically visible exposed bone 4. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit 5. Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \>0.7 and \<1.3, 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. 6. Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1 7. Index wound is free of necrotic debris prior to NeoThelium FT application 8. Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit 9. Wound free of clinical signs/symptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and prior to the first treatment visit. 10. Subject is able and willing to follow the protocol requirements 11. Subject had signed informed consent 12. If 2 or more wounds are present, the wounds must be separated by at least 2 cm Exclusion Criteria: 1. Subject is unable to comply with protocol treatment 2. Presence of infection prior to screening. 3. Multiple VLUs on the same leg with \< 2 cm separation from the target ulcer. 4. Subject has comorbid conditions that may compromise subject safety or wound healing in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders 5. Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound. 6. Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator 7. Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT. 8. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing. 9. Subject is pregnant or breastfeeding 10. 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 11. Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment 12. Index ulcer suspicious of neoplasm in the opinion of the principal investigator
is designated in this study