Borate-based Bioactive Glass Fiber Matrix (BBGFM) in the Treatment of Venus Leg Ulcers (VLU)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorETS Wound Care, LLC
About this trial
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
Eligibility criteria
Qualifiers
Male or Female, 18 years of age or older
Participant has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound. Venous etiology confirmed by duplex ultrasound of the affected limb performed within 90 days prior to randomization, demonstrating superficial and/or deep venous reflux (≥0.5 seconds) in the examined venous segments and no evidence of acute deep venous thrombosis.7, 8
Participant has a venous leg ulcer present for ≥4 weeks and ≤18 months prior to screening, as documented in the medical record.
The target wound must demonstrate ≤50% reduction in wound area following minimum of 28 consecutive days of continuous therapeutic compression at Randomization (Day 1).
Disqualifiers
Participant does not have a diagnosis of venous leg ulcer or venous insufficiency with a wound located on the lower extremity.
Participant has a known life expectancy of <1 year.
Participant is unable to comply with protocol treatment.
Participant has comorbid conditions, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders. that may compromise participant's safety or wound healing in the opinion of the Investigator.
Trial design
Treatments tested in this trial
- Borate Based Bioactive Glass Fiber Matrix (BBGFM)
Treatment groups
110 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov