Comparing Hyalomatrix Plus Standard Care to Standard Care Alone for Healing Chronic Venous Leg Ulcers in Adults

What this Trial Is About

Researchers are evaluating the effectiveness of Hyalomatrix, a hyaluronic acid-based wound dressing, combined with standard of care SOC compared to SOC alone in treating venous leg ulcers. This open-label, randomized controlled trial includes adults diagnosed with venous leg ulcers or venous insufficiency with lower extremity wounds, aiming to assess wound healing over a 12-week period and support insurance reimbursement decisions. Participants will be randomly assigned to either receive SOC alone, which includes wound cleansing, sharps debridement, moisture-balancing dressings, and compression therapy, or SOC plus weekly Hyalomatrix applications. Subjects in the SOC group who do not achieve complete wound closure by about 84 days post-randomization and meet eligibility criteria may cross over to receive Hyalomatrix treatment for up to 12 weeks while continuing follow-up visits. During the study, participants will attend treatment visits where wound healing progress, pain levels, and wound area reduction are monitored regularly. Researchers will measure complete wound closure within 1 to 12 weeks as the primary outcome, along with weekly percentage area reduction and pain assessments for up to 14 weeks. The study emphasizes ongoing safety and efficacy monitoring throughout the treatment and follow-up periods.

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