Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers: A Randomized Controlled Multicenter Crossover Trial
NuScience Medical Biologics, LLC
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.
Description
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will be randomly assigned to one of two groups: either standard of care (SOC) alone, or SOC plus Hyalomatrix. The study includes a crossover component for subjects in the SOC arm. At treatment visit 13 (approximately 84 days post-randomization), SOC arm subjects not having achieved complete wound closure, and still meeting the inclusion/exclusion criteria, a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or Female, 18 years of age or older 2. Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound 3. 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 4. Subject has a venous leg ulcer with a historical wound measurement showing less than 25% healing within 14 days prior to screening 5. Subject has a venous leg ulcer with screening wound measurement showing less than 25% healing within 14 days prior to rando…
Interventions
- DeviceHyalomatrix
Hyalomatrix is a hyaluronic acid-based wound dressing designed for advanced wound therapy.
- OtherStandard of Care
Wound cleansing, Sharps debridement, Dressing for moisture balance, Compression therapy
Locations (4)
- MedCentris of AlexandriaAlexandria, Louisiana
- MedCentris of PinevillePineville, Louisiana
- MedCentris of VidailaVidalia, Louisiana
- MedCentris of ClevelandCleveland, Mississippi