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).

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Boise, Idaho, United States, 83702
      • Boise VAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with a diabetic foot ulcer referred to the High Risk Foot Clinic at Boise VAMC who meet the inclusion criteria, and are willing and able to participate will be enrolled.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limb salvage	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.	One month past wound healing

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetic Foot Ulcer Quality of life Short Form survey	Quality of life measured at enrollment in study, at wound healed, one month post-healed, and 2-4 months later.	Comparison of patient's perception at enrollment, wound heal, one month, and 2-4 months after the wound is healed.

Collaborators and Investigators

• Sponsor: Boise VA Medical Center
• Collaborators: Integra LifeSciences Corporation
• Investigators: Principal Investigator: Margaret Doucette, D. O., Boise VAMC; Study Director: Kattie B Payne, PhD, RN, MSN, Boise VAMC

Publications and helpful links

General Publications

• 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.
• 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
• Doucette M, Payne KM, Lough W, Beck A, Wayment K, Huffman J, Bond L, Thomas-Vogel A, Langley S. Early Advanced Therapy for Diabetic Foot Ulcers in High Amputation Risk Veterans: A Cohort Study. Int J Low Extrem Wounds. 2022 Jun;21(2):111-119. doi: 10.1177/1534734620928151. Epub 2020 Jun 22.

Study record dates

Study Major Dates

• Study Start: May 30, 2015
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimated): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: wound healing; diabetic foot ulcer; foot ulcer, diabetic
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 00816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study.