Venus Leg Ulcer (VLU)NCT07647705
Borate-based Bioactive Glass Fiber Matrix (BBGFM) in the Treatment of Venus Leg Ulcers (VLU)
A study testing Borate Based Bioactive Glass Fiber Matrix (BBGFM) in people with Venus Leg Ulcer (VLU) and VLU, run by ETS Wound Care, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venus Leg Ulcer (VLU), VLU, Venus Leg Ulcer
- What is being tested?
- Borate Based Bioactive Glass Fiber Matrix (BBGFM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are required to meet the following inclusion criteria before entering the study:
- 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).
- For participants with clinical site medical records documenting a wound measurement, wound photography, and continuous therapeutic compression for >14 days prior to the Screening Visit, an accelerated 14-day screening period will be followed.
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- A documented wound measurement in medical record obtained >14 days prior to Screening Visit will serve as the reference measurement. The same wound measurement method (e.g., manual planimetry or a digital wound measurement system) must be used for all comparative assessments prior to randomization.
- At Screening Visit: The target wound must demonstrate ≤50% reduction in wound area following 14 consecutive days of SOC continuous therapeutic compression at screening compared with the reference measurement.
- At Randomization: After completion of a 14 day run in period of continuous therapeutic compression, the target wound must demonstrate ≤50% reduction at Randomization (Day 1) compared with the reference measurement (>28 days prior to randomization).
- For participants without qualifying clinical site medical records, a traditional 28-day screening period will be followed.
- The wound measurement obtained at Screening Visit will be the reference measurement.
- At Randomization: After completion of a 28 day run in period of continuous therapeutic compression, the target wound must demonstrate ≤50% reduction in wound area at Randomization (Day 1) compared with the reference measurement (>28 days prior to randomization).
- Target wound is between 2.0 cm² to ≤20.0 cm² at Randomization. Wound area will be measured at each visit using standardized digital planimetric measurement (standardized camera distance/lighting and calibration); historical and screening percent area change calculations must use the same method.
- Adequate arterial perfusion demonstrated by one of the following:
- ABI ≥0.7 and ≤1.3 OR TBI ≥0.6, obtained within 30 days prior to randomization
- If ABI is >1.3 (noncompressible) or borderline, TBI or arterial duplex must be obtained to confirm adequate perfusion
- Tcom ≥40mmHg
- Target wound must be free of necrotic debris prior to application of MIRRAGEN® or standard of care (target wound bed is adequately debrided such that no adherent necrotic eschar or slough obscures wound bed assessment, and the wound is suitable for study product application per Investigator). 9, 10
- Females of childbearing potential must have a negative serum β-hCG at Screening, performed within 14 days prior to Randomization, and a negative urine pregnancy test at Randomization (Day 1) prior to receipt of study treatment. If the initial serum βhCG result is more than 14 days old at the time of Randomization, the serum β hCG test must be repeated to ensure it remains within the 14-day window.
- Target wound must be non-infected at Screening and Randomization. Non-infected is defined as absence of ≥2 local clinical signs (swelling/induration, erythema beyond margin, increased warmth, new/increased pain/tenderness, or purulent exudate) and absence of systemic signs (fever or leukocytosis), consistent with Wound Healing Society (WHS) guidelines. Any infection present before or during the run-in period must be treated, and resolution must be documented prior to Randomization.
- If two or more wounds are present, the wounds must be separated by at least 2 cm.
- Participant has no more than 5 other wounds on the index leg.
- CEAP classification is not required as an eligibility criterion. Doppler waveform assessment (biphasic or triphasic signal) will not be used as an eligibility criterion. If there is more than one wound present, the largest qualifying wound will be the target wound.
- Participant is able and willing to follow the protocol requirements.
Who cannot join
- Patients will be excluded if they meet any of the following exclusion criteria:
- 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.
- Participant actively (or having a history) being treated for malignant disease, or history of malignancy or radiation therapy at the site of wound.
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- HbA1c >12% (HbA1c must be ≤12% at screening, measured within 30 days prior to Randomization (Christman et al. 2011, Snyder et al. 2010), or renal failure defined as eGFR <30 mL/min/1.73m² (CKD stage 4-5) at Screening, or end-stage renal disease requiring dialysis).
- Known contraindications to bioabsorbable advanced wound matrix
- Concurrent participation in alternative clinical trial that involves investigational drug or cellular, acellular, and matrix-like products that may interfere with wound treatment and/or healing
- Participant is pregnant or breastfeeding.
- History of immunosuppressant treatment (systemic corticosteroids >10mg/ day), cytotoxic chemotherapy, or topical steroid application to the wound for >2 weeks within 30 days prior to Randomization, or anticipated use of any of the above during the course of the study
- Wound previously treated with cellular, acellular, or matrix-like products, tissue engineered constructs, or scaffold materials within 30 days prior to Randomization
- Wound depth with visible exposed bone or hardware
- Hyperbaric oxygen therapy (HBO) or Negative Pressure Wound Therapy (NPWT) within 28 days prior to Randomization
- Planned or recent (within 30 days prior to Screening) revascularization surgery/procedure or venous intervention of the target wound limb, including arterial revascularization (endovascular or open bypass), or anticipated need for revascularization during the treatment period, as determined by vascular assessment
- For arterial procedure: including but not limited to endovascular or open bypass
- For venous procedures: including but not limited to endovenous ablation, surgical ligation/stripping, or perforator vein procedures
- Target wound suspicious of neoplasm in the opinion of the Principal Investigator
- Multiple venous leg ulcers on the same leg with <2 cm² separation from the target wound
- Inability to tolerate the protocol-approved compression therapy
- Stage II or Stage III lymphedema as defined by the Society of Lymphology
- Body mass index (BMI) >45 kg/m² at Screening. Participants with BMI >45 kg/m² will be excluded due to the potential for impaired mobility, difficulties with consistent application or tolerance of therapeutic compression, and increased risk of confounding factors that may adversely affect venous leg ulcer healing.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase IV, Post-market, Randomized, Controlled, Open-label, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of MIRRAGEN® Advanced Wound Matrix Plus Standard of Care Compared With Standard of Care Alone in Achieving Complete Wound Closure in Participants With Venous Leg Ulcers by 12 Weeks.
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:
- Does BBGFM help Venus Leg Ulcers heal completely in 12 weeks?
Read more
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
- Being tested
- Borate Based Bioactive Glass Fiber Matrix (BBGFM)
- Keywords
- Mirragen, BBGFM, Borate-base Bioactive Glass Fiber Matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Borate Based Bioactive Glass Fiber Matrix (BBGFM)Device
Application of BBGFM to wound site along with standard of care treatment
| Study group | Role | What they receive |
|---|---|---|
| Borate-based Bioactive Glass Fiber Matrix (BBGFM) plus Standard of Care | Experimental | Not described Receives: Device: Borate Based Bioactive Glass Fiber Matrix (BBGFM) |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Healing
The proportion of subjects achieving complete wound closure.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venus Leg Ulcer (VLU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ETS Wound Care, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647705
- Sponsor's protocol ID
- ETS_VLU_01
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Post-market, Randomized, Controlled, Open-label, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of MIRRAGEN® Advanced Wound Matrix Plus Standard of Care Compared With Standard of Care Alone in Achieving Complete Wound Closure in Participants With Venous Leg Ulcers by 12 Weeks.
- ClinicalTrials.gov ID
- NCT07647705
- Acronym / sponsor ID
- ETS_VLU_01
- Conditions
- Venus Leg Ulcer (VLU), VLU, Venus Leg Ulcer, Venus Ulcer
- Keywords
- Mirragen, BBGFM, Borate-base Bioactive Glass Fiber Matrix
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- ETS Wound Care, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Borate-based Bioactive Glass Fiber Matrix (BBGFM) plus Standard of Care | Experimental | Device: Borate Based Bioactive Glass Fiber Matrix (BBGFM) |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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).
- Target wound is between 2.0 cm² to ≤20.0 cm² at Randomization. Wound area will be measured at each visit using standardized digital planimetric measurement (standardized camera distance/lighting and calibration); historical and screening percent area change calculations must use the same method.
Key exclusion criteria (22 listed)
- 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.
- Participant actively (or having a history) being treated for malignant disease, or history of malignancy or radiation therapy at the site of wound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Borate Based Bioactive Glass Fiber Matrix (BBGFM)Application of BBGFM to wound site along with standard of care treatment | Device | Borate-based Bioactive Glass Fiber Matrix (BBGFM) plus Standard of Care |
Primary outcome
Complete Wound Healing
Time frame: 12 weeks
The proportion of subjects achieving complete wound closure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Borate Based Bioactive Glass Fiber Matrix (BBGFM) in people with Venus Leg Ulcer (VLU) and VLU, run by ETS Wound Care, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donnie W. Buck, III, MD, FACS (410-490-5998, dbuck@etswoundcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Wound Healing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.