Not Yet RecruitingNot Applicable

Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers

122 participantsStarted 2026-05-18

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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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 leg ulcer or venous insufficiency with a lower extremity wound
✓. 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 25% healing within 14 days prior to screening
✓. Subject has a venous leg ulcer with screening wound measurement showing less than 25% healing within 14 days prior to randomization
✓. Subject has a 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.

Exclusion criteria

✕. Subject does not have a diagnosis of venous leg ulcer or venous insufficiency with a wound located on the lower extremity
✕. Subject has a known life expectancy of \<1 year
✕. Subject is unable to comply with protocol treatment
✕. 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 to tissue-engineered allograft
✕. Concurrent participation in alternative clinical trial that involves investigational drug or HCT/P interfering with wound treatment and/or healing.

What they're measuring

Complete Wound Closure

Timeframe: 1-12 weeks

Trial details

NCT IDNCT07335861

SponsorNuScience Medical Biologics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Sarah Moore

985-629-4013 sarah.moore@sygnola.com

View on ClinicalTrials.gov More Venous Leg Ulcer trials