Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue



Status:Active, not recruiting
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:1/21/2018
Start Date:July 2015
End Date:September 2019

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Trial Summary
Trial Overview
Inclusion Criteria

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
We found this trial at
1
site
Boise VAMC
500 West Fort Street
Boise, Idaho 83702
Phone: 208-422-1368
?
mi
from
Boise, ID
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