RecruitingNot ApplicableNCT07061613

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers

Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Venous Leg Ulcers: A Prospective Case Series

Sponsor

NuScience Medical Biologics, LLC

Enrollment

10 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers

Min Age: 18 Years

Male or Female, 18 years of age or older
Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound
Subject has an venous leg ulcer without infection or clinically visible exposed bone
Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit
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.
Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1
Index wound is free of necrotic debris prior to NeoThelium FT application
Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit
Wound free of clinical signs/symptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and prior to the first treatment visit.
Subject is able and willing to follow the protocol requirements
Subject had signed informed consent
If 2 or more wounds are present, the wounds must be separated by at least 2 cm

Subject is unable to comply with protocol treatment
Presence of infection prior to screening.
Multiple VLUs on the same leg with \< 2 cm separation from the target ulcer.
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
Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound.
Subject has comorbid conditions that may compromise subject safety in the opinion of the investigator
Known contraindications or hypersensitivity to amniotic membrane products or components of NeoThelium FT.
Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.
Subject is pregnant or breastfeeding
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
Wound previously treated with CAMPs, tissue engineered, or scaffold materials within 30 days prior to enrollment
Index ulcer suspicious of neoplasm in the opinion of the principal investigator