Human Amniotic Membrane(s) On Venous Leg Ulcers In an Elderly Population

This study is designed to assess the clinical effectiveness of human amniotic membrane(s) for the management of difficult to heal partial- or full-thickness venous leg ulcers (VLUs)

Multi-center (up to 25 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 lite™, CT Shield™, Membrane wrap™ and Membrane wrap hydro™ versus Standard of Care (SOC) in subject with eligible venous leg ulcers.

Eligibility Criteria:
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).
2. Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy
3. Venous insufficiency ulcers between 2 cm2 and 32 cm2
4. Venous ulcer has not reduced in area ≥40% from baseline measurements during the 2-week screening period
5. 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 (reticular dermis) but not through muscle, tendon, capsule, or into bone.
6. Subjects are between 50 and 85 years of age.
7. IRB approved Informed Consent Form is signed before screening and treatment.
8. Subject is expected to be available for 12-week follow-up
9. Subjects with bilateral ulcers may be enrolled.
10. Subject, or their Legally Authorized Representative (LAR), has read, understood, and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from participating in this study:

1. Ankle Brachial Index (ABI) of \<0.7 or Toe Brachial Index (TBI) \<.5
2. Venous insufficiency ulcers less than 2cm2 or greater than 32cm2
3. Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases
4. Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease
5. Signs and symptoms of infection, cellulitis, osteomyelitis
6. Necrotic ulcer beds
7. Ulcer with exposed bone or tendon
8. Subjects receiving hemodialysis or have uncontrolled diabetes: defined as A1C of ≤12.
9. 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.
10. Subjects enrolled in other wound drug investigational studies within the past three months, or device studies within the past 30 days.