Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population

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
• •3. Venous insufficiency ulcers between 2 cm2 and 16 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
• •6. Subjects are between 50 and 85 years of age.
• •7. Subject is expected to be available for 12-week follow-up
• •8. 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:
• +10 more criteria