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

NCT07647705 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-06-15

No results posted yet for this study

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

Conditions

  • Venus Leg Ulcer (VLU)
  • VLU
  • Venus Leg Ulcer
  • Venus Ulcer

Interventions

DEVICE

Borate Based Bioactive Glass Fiber Matrix (BBGFM)

Application of BBGFM to wound site along with standard of care treatment

Sponsors & Collaborators

  • ETS Wound Care, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-01-31
Completion
2028-01-31
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07647705 on ClinicalTrials.gov