Overview
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)
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.
Eligibility
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.