Venus Leg Ulcer, Venus Leg Ulcer (VLU), Venus Ulcer, VLU
Conditions
Keywords
Mirragen, BBGFM, Borate-base Bioactive Glass Fiber Matrix
Brief 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
Interventions
DEVICEBorate Based Bioactive Glass Fiber Matrix (BBGFM)
Application of BBGFM to wound site along with standard of care treatment
Sponsors
ETS Wound Care, LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients are required to meet the following inclusion criteria before entering the study: 1. Male or Female, 18 years of age or older 2. 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 3. Participant has a venous leg ulcer present for ≥4 weeks and ≤18 months prior to screening, as documented in the medical record. 4. The target wound must demonstrate ≤50% reduction in wound area following minimum of 28 consecutive days of continuous therapeutic compression at Randomization (Day 1). a. 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. i. 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. ii. 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. iii. 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). b. For participants without qualifying clinical site medical records, a traditional 28-day screening period will be followed. i. The wound measurement obtained at Screening Visit will be the reference measurement. ii. 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). 5. 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. 6. 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 7. 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 8. 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. 9. 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. 10. If two or more wounds are present, the wounds must be separated by at least 2 cm. 11. Participant has no more than 5 other wounds on the index leg. 12. 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. 13. Participant is able and willing to follow the protocol requirements.
Exclusion criteria
Patients will be excluded if they meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Healing | 12 weeks | The proportion of subjects achieving complete wound closure. |
Contacts
CONTACTDonnie W. Buck, III, MD, FACS
CONTACTGregory C Manista, MD
Outcome results
None listed