NCT07335861

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

Evaluation of the Efficacy of Hyalomatrix® in the Healing of Chronic Venous Leg Ulcers: A Randomized Controlled Multicenter Crossover Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: NuScience Medical Biologics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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, are eligible to crossover to the IP arm (SOC plus Hyalomatrix). Crossover subjects will begin IP arm treatment with weekly Hyalomatrix applications for up to 12 treatment visits. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.

Conditions

• Venous Leg Ulcer
• Chronic Wounds

Interventions

Type	Name	Description
DEVICE	Hyalomatrix	Hyalomatrix is a hyaluronic acid-based wound dressing designed for advanced wound therapy.
OTHER	Standard of Care	Wound cleansing, Sharps debridement, Dressing for moisture balance, Compression therapy

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-10-01
• Completion: 2026-12-31
• First posted: 2026-01-13
• Last updated: 2026-01-13

Regulatory

• FDA-regulated device study