Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population

Inclusion Criteria20

• 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.