L'étude est conçue pour tester l'efficacité et la sécurité d'un nouveau produit de greffe cutanée appelé NeoThelium FT pour le traitement des ulcères veineux de la jambe. Les ulcères veineux de la jambe sont des plaies ouvertes sur la jambe causées par une mauvaise circulation sanguine, et elles peuvent être difficiles à guérir. Cette recherche est importante car elle vise à améliorer les résultats de guérison pour les patients atteints de ces ulcères, potentiellement en rendant le traitement plus efficace et en aidant les compagnies d'assurance à décider de la couverture. L'étude se déroule dans plusieurs centres médicaux et implique des participants qui ont accepté de se joindre et qui répondent à des critères spécifiques. Les participants à l'étude recevront leurs soins standards plus des applications hebdomadaires de la greffe cutanée NeoThelium FT. Les chercheurs et les participants savent tous deux quel traitement est administré, ce qui est connu sous le nom d'étude en ouvert. Les participants suivront un calendrier de contrôles pour surveiller leur progression. L'étude vise à collecter des données sur l'efficacité du traitement et sur son aide dans les décisions de remboursement par les assurances. Ces informations pourraient conduire à de meilleures stratégies de traitement pour les personnes souffrant d'ulcères veineux de la jambe.
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
est désigné dans cette étude