CompletedNot Applicable

Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue

United States20 participantsStarted 2015-05-30

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Limb salvage

Timeframe: One month past wound healing

Trial details

NCT IDNCT02632929

SponsorBoise VA Medical Center

Sponsor typeFED

Study typeOBSERVATIONAL

Primary completion2019-08-31

View on ClinicalTrials.gov More Diabetic Foot Ulcer trials