Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue

Completed

Conditions studied: Diabetic Foot Ulcer

In brief

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).

Key facts

Study ID

NCT02632929

Run by

Boise VA Medical Center

People needed

20

Starts

2015-05-30

Expected to finish

2019-09-30

Last updated by the study team

2023-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Boise VAMC — Boise, Idaho, United States

Full record on ClinicalTrials.gov

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