Evaluating the Efficacy of NeoThelium FT in the Treatment of Venous Leg Ulcers

Starting soon · Not applicable

Conditions studied: Venous Leg Ulcer

In brief

This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.

Key facts

Study ID

NCT06930768

Run by

NuScience Medical Biologics, LLC

People needed

132

Starts

2026-07-01

Expected to finish

2027-06-01

Last updated by the study team

2026-04-13

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 Insufficiency with an open wound to the lower extremity
• Subject has a Venous Leg Ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
• Subject has a Venous Leg Ulcer with a historical wound measurement showing less than 50% healing in 30 days prior to randomization
• Subject has a Venous Leg Ulcer with screening wound measurement showing less than 25% healing in 14 days prior to randomization
• Subject has a Venous Leg Ulcer Wagner 1, 2, and 3 without infection or clinically visible exposed bone
• Index ulcer is a minimum of 1cm2 and a maximum of 40cm2 at first treatment visit
• Venous Leg Ulcer is being treated with compression therapy for 14 days prior to randomization
• Adequate circulation of ulcer demonstrated by an ABI of >0.7 and <1.3, or TBI of >0.6 within 30 days prior to randomization
• Index ulcer is free of infection prior to randomization and during screening phase noted with the NERDS Assessment. Infection must be adequately treated and controlled prior to randomization.
• Index ulcer is free of necrotic debris prior to NeoThelium FT application
• Female subjects of childbearing potential having a negative pregnancy test prior to randomization
• Subject is able and willing to follow the protocol requirements
• Subject had signed informed consent
• If 2 or more ulcers are present, the ulcers must be separated by at least 1 cm

You may not qualify if…

• Subject has a known life expectancy of <1 year
• Subject is unable to comply with protocol treatment
• 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
• 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 to tissue-engineered allograft
• Concurrent participation in alternative clinical trial that involves investigational drug or product interfering with wound treatment and/or healing
• Wound reduces in area by ≥25% after 14 days of SOC prior to randomization
• 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 randomization; 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 randomization
• Venous Leg Ulcer with active infection
• Wound depth with visible exposed bone
• HBOT within 14 days prior to randomization
• Revascularization surgery on the index ulcer leg within 30 days of screening phase
• Index ulcer suspicious of neoplasm in the opinion of the principal investigator

Full record on ClinicalTrials.gov

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