Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue

Overview

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).

Full Title of Study: “Prevention of Amputation in a High Risk Population With Comprehensive Care and Amniotic Tissue”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 31, 2019

Detailed Description

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.

Arms, Groups and Cohorts

  • Diabetic Foot Ulcers at Amputation Risk
    • Patients at high risk for limb amputation from a diabetic foot ulcer will be treated with comprehensive, interdisciplinary approach (usual care) in combination with early application of advanced therapy; dehydrated human amniotic membrane allografts (AMNIOEXCEL®, Derma Science, Princeton, New Jersey).

Clinical Trial Outcome Measures

Primary Measures

  • Limb salvage
    • Time Frame: One month past wound healing
    • All subjects will be seen weekly/biweekly by the study team until the point of definitive wound closure (epithelialization) and the subject has the ability to progress weight bearing and ambulation.

Secondary Measures

  • effective wound healing
    • Time Frame: One month past wound healing
    • Early application of amniotic tissue and multidisciplinary team comprehensive care on diabetic foot ulcers with a high risk for amputation

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boise VA Medical Center
  • Collaborator
    • Integra LifeSciences Corporation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Margaret Doucette, Director, Physical Medicine and Rehabilitation – Boise VA Medical Center
  • Overall Official(s)
    • Margaret Doucette, D. O., Principal Investigator, Boise VAMC
    • Kattie B Payne, PhD, RN, MSN, Study Director, Boise VAMC

References

Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.

Abetz, L., Sutton, M., Brady, L., McNulty, P., Gagnon, D. The Diabetic Foot Ulcer Scale (DFS): a quality of life instrument for use in clinical trials. Pract Diab Int July/August 2002 Vol 19 No. 6

Bann CM, Fehnel SE, Gagnon DD. Development and validation of the Diabetic Foot Ulcer Scale-short form (DFS-SF). Pharmacoeconomics. 2003;21(17):1277-90. doi: 10.2165/00019053-200321170-00004.

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