Not Yet RecruitingNot Applicable

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

132 participantsStarted 2026-07-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Complete Wound Closure

Timeframe: 1-12 weeks

Trial details

NCT IDNCT06930768

SponsorNuScience Medical Biologics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-01

Contact for this trial

Angelina Ferguson, DNP

(985) 629-4013 info@sygnola.com

View on ClinicalTrials.gov More Venous Leg Ulcer trials