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

Recruiting now · Not applicable

Conditions studied: Venous Leg Ulcer

In brief

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

Key facts

Study ID

NCT07061613

Run by

NuScience Medical Biologics, LLC

People needed

10

Starts

2025-09-02

Expected to finish

2026-07-29

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MedCentris of Slidell — Slidell, Louisiana, United States (enrolling)
• MedCentris of Metairie — Metairie, Louisiana, United States

Full record on ClinicalTrials.gov

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