A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds

A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds

This research project is testing a product called AmnioClear™ which is an amniotic membrane graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClear™ allograft human amniotic membrane is regulated solely under section 361 of the Public Health Service Act.

The purpose of the study is to see if this treatment works to accelerate the healing time of chronic wounds.

Inclusion Criteria:

• Stable Type I or II diabetes mellitus
• At least one chronic diabetic ulcer
• Full-thickness ulcer size from 1-8 cm2.

Exclusion Criteria:

• Concurrent use of corticosteroids, NSAIDs immuno-suppressive or cytotoxic agents
• Bleeding disorders
• Ulcer with muscle, tendon, capsule or bone involvement