Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population
Not Applicable
Recruiting
- Conditions
- Venous Leg Ulcer
- Interventions
- Device: Membrane-Wrap Lite™Other: Standard of CareDevice: CT-Shield™Device: Membrane Wrap - Hydro™Device: Membrane Wrap™
- Registration Number
- NCT06544564
- Lead Sponsor
- BioLab Holdings
- Brief Summary
This study is designed to assess the clinical effectiveness of Membrane Wrap, a human amniotic membrane for the management of difficult to heal partial- or full-thickness venous leg ulcers (VLUs)
- Detailed Description
Multi-center (up to 20 sites), prospective, randomized trial assess the clinical effectiveness of human amniotic membrane(s) for the management of difficult to heal partial- or full-thickness venous leg ulcers (VLUs). The primary objective is to evaluate the effectiveness of Membrane wrap™ versus Standard of Care (SOC) in subject with eligible venous leg ulcers.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
In order to be eligible to participate in this study, subjects must meet all of the following criteria:
- Ulcers of venous origin, as determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test). If the subject has multiple on the same leg and/or bilateral ulcers, the largest should be selected.
- Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy
- Venous insufficiency ulcers between 2 cm2 and 16 cm2
- Venous ulcer has not reduced in area ≥40% from baseline measurements during the 2-week screening period
- Partial- or full-thickness VLU, including ulcers with tissue damage that extends through the epidermis and into the upper epidermis (papillary dermis), or into the deep dermis
- Subjects are between 50 and 85 years of age.
- Subject is expected to be available for 12-week follow-up
- Subject, or their Legally Authorized Representative (LAR), has read, understood, and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.
Subjects who meet any of the following criteria will be excluded from participating in this study:
- Ankle Brachial Index (ABI) of <0.7 or Toe Brachial Index (TBI) <0.5
- Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases
- Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease
- Signs and symptoms of infection, cellulitis, osteomyelitis
- Necrotic ulcer beds
- Subjects receiving hemodialysis or have uncontrolled diabetes: defined as A1C of greater than or equal to 12. An existing A1C value is allowed if completed within 3 months of subject screening.
- Subjects who are currently receiving or have received at any time within one month prior to entry into the study, corticosteroids (>15 mg/day), immunosuppressive agents, radiation therapy, or chemotherapy. Anticipated use of the above agents will exclude subjects from entry into the study.
- Wound unable to be debrided or subject not able to tolerate debridement
- Subject not willing or able to comply with compression requirements
- Subjects enrolled in other wound investigational studies within the past three months, or device studies within the past 30 days.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1- Membrane-Wrap Lite™ plus SOC Membrane-Wrap Lite™ Membrane-Wrap Lite™ plus SOC Membrane- Wrap Lite™: is a human tissue allograft derived from amniotic membrane that provide structural tissue for use as a wound and protectant covering. It is a single-layer human tissue allograft, containing solely the amnion layer of Amniotic Membrane \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271. Group will receive the assigned biologic plus Compression treatment per Wound Healing Society guidelines "Compression for treatment of Venous Ulcers" SOC treatment Group 5: SOC only Standard of Care Group 5: Standard of Care only- Subjects randomized to Group 5 (SOC, or Active Control treatment) will not receive Biologic, but will receive SOC alone. SOC) is defined as: Compression treatment per Wound Healing Society guidelines, "Compression for treatment of Venous Ulcers" \[10\]. SOC, or Active Control treatment, is defined as: 1) debridement of non-viable, necrotic tissue, 2) application of a primary, wound contact dressing that maintains moisture balance, 3) application of a Class 3 high compression system, and 4) wrapping with a covering, tertiary dressing. A Class 3 (most supportive) high-compression system is required. High compression bandages provide and maintain high levels of compression pressures in the range 25-35 mm Hg at the ankle. High strength compression can be applied successfully using many methods including multilayered elastic compression, inelastic compression, Unna's boot, compression stockings, and other. Group 2- CT-Shield™ plus SOC CT-Shield™ CT-Shield™ plus SOC- CT Shield™: is a human tissue allograft derived from the amniotic membrane that provides protection, coverage and shielding for connective tissue. It is a triple-layered human tissue allograft, containing amnion-chorion-amnion layers \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271. Group will receive the assigned biologic plus Compression treatment per Wound Healing Society guidelines "Compression for treatment of Venous Ulcers" SOC treatment Group 4: Membrane Wrap - Hydro™ plus SOC Membrane Wrap - Hydro™ Group 4: Membrane Wrap - Hydro™ plus SOC- Membrane Wrap Hydro™: is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. It is a saline-hydrated human tissue allograft \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271. Group will receive the assigned biologic plus Compression treatment per Wound Healing Society guidelines, "Compression for treatment of Venous Ulcers" SOC treatment Group 3: Membrane Wrap™ plus SOC Membrane Wrap™ Group 3: Membrane Wrap™ plus SOC- Membrane Wrap™: is a human tissue allograft derived from the amniotic membrane that provides structural tissue for use as a wound and protectant covering. It is a human tissue allograft \[Human Cellular and Tissue Based Product (HCT/P)\] for transplantation regulated by the US Food and Drug Administration under 21 CFR Part 1271.Group will receive the assigned biologic plus Compression treatment per Wound Healing Society guidelines "Compression for treatment of Venous Ulcers" SOC treatment
- Primary Outcome Measures
Name Time Method Time to wound closure by or on week 12. 12 weeks Wound Closure is defined as:
* Full epithelialization of the wound with the absence of drainage
* Epithelialization is defined as a layer of epithelium visible on the wound surfaceFrequency of wound closure by or on week 12. 12 weeks Wound Closure is defined as:
* Full epithelialization of the wound with the absence of drainage
* Epithelialization is defined as a layer of epithelium visible on the wound surface
- Secondary Outcome Measures
Name Time Method Rate of VLU improvement by or on End of Study (EOS) from baseline 12 weeks defined by:
* \>60% reduction in area, or
* \>60% reduction in depth, or
* \>75% reduction in volume Rate of VLU improvement by or on End of Study (EOS) from baseline
Trial Locations
- Locations (4)
Center for Clinical Research
🇺🇸San Francisco, California, United States
Biophase Research
🇺🇸North Miami Beach, Florida, United States
Doctors Research Network
🇺🇸South Miami, Florida, United States
Advantage Foot Care of Houston
🇺🇸Houston, Texas, United States