Clinical Trial

Borate-based Bioactive Glass Fiber Matrix (BBGFM) in the Treatment of Venus Leg Ulcers (VLU)

Not Yet Recruiting
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Summary
The goal of this clinical trial is to learn if Borate-based Bioactive Glass Fiber Matrix (BBGFM) can help heal Venous Leg Ulcers (VLU) that have not closed with standard treatment. The main question it aims to answer is: 1\. Does BBGFM help Venus Leg Ulcers heal completely in 12 weeks? Researchers will compare BBGFM plus Standard of Care (SOC) to SOC alone to see if BBGFM works to heal wounds. Participants will: * Have BBGFM applied to their wound (if assigned to the BBGFM group) for up to 12 applications * Visit the clinic each week for wound checks and tests Other study purposes include looking at: * The time it takes for the wound to heal * Changes in wound size over time * The durability of wound healing after closure * The use of healthcare resources related to wound care * Any adverse events (side effects) or reactions related to the treatment * Changes in pain levels * Changes in quality of life
Trial Details
NCT Number NCT07647705
Lead Sponsor ETS Wound Care, LLC
Conditions Venus Leg Ulcer (VLU), VLU, Venus Leg Ulcer, Venus Ulcer
Enrollment 110 participants
Start Date 2026-07
Primary Completion 2027-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-15