A Multi-Center, Prospective, Randomized Trial Evaluating the Efficacy of Membrane Wrap, A Human Amniotic Membrane on Venous Leg Ulcers in an Elderly Population
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Venous Leg Ulcer
- Sponsor
- BioLab Holdings
- Enrollment
- 150
- Locations
- 9
- Primary Endpoint
- Time to wound closure by or on week 12.
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
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:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Time to wound closure by or on week 12.
Time Frame: 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
Frequency of wound closure by or on week 12.
Time Frame: 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 Outcomes
- Rate of VLU improvement by or on End of Study (EOS) from baseline(12 weeks)