Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue

Prevention of Amputation in a High Risk Population With Comprehensive Care and Amniotic Tissue

The purpose of this study is to see whether the use of AMNIOEXCEL® improves healing and reduces the need to cut off all or part of a leg (amputation) in high-risk patients who have diabetes and foot sores (also sometimes called ulcers or wounds).

The purpose of this study is to demonstrate the effectiveness of comprehensive, interdisciplinary approach (usual care) in combination with early application of advanced therapy; dehydrated human amniotic membrane allografts (AMNIOEXCEL®, Derma Science, Princeton, New Jersey) in healing and preventing amputation in high risk patients with diabetic foot ulcers.

Inclusion Criteria:

• Type 1 or 2 diabetes
• Ulcer anywhere on the foot
• Moderate to high risk for amputation according to Prevention of Amputation for Veterans Everywhere (PAVE) and the Society for Vascular Surgery Lower Extremity Threatened Limb (SVS WIfI) classification system (WIFi) criteria

Exclusion Criteria:

• Inability or unwillingness to travel to Boise VA for clinic visits
• Enrolled in Hospice
• Have known or expected malignancy of foot ulcer
• Are or planning to become pregnant
• Signs of progressive gangrene, limb-threatening infection