BioLab Holdings
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)
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.
Inclusion Criteria: In order to be eligible to participate in this study, subjects must meet all of the following criteria: 1. 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. 2. Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy…
Membrane Wrap™
SOC treatment will be defined as: 1) debridement of non-viable, necrotic tissue, 2) application of Biologic as the primary, wound covering, 3) application of a dressing over Biologic that maintains moisture balance, 4) application of a Class 3 high compression system, and 5) wrapping with a covering dressing