Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue

NCT02632929 | Completed

• 1 other identifier: 00816
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetic Foot Ulcer

Keywords

foot ulcer, diabetic; wound healing; diabetic foot ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• effective wound healing

  One month past wound healing

Other Outcomes (1)

• Diabetic Foot Ulcer Quality of life Short Form survey

  Comparison of patient's perception at enrollment, wound heal, one month, and 2-4 months after the wound is healed.

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Boise VA Medical Center: lead
• Integra LifeSciences Corporation: collaborator

Study Sites (1)

Boise VAMC

Boise, Idaho, 83702, United States

Location

Related Publications (4)

• 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.

  PMID: 24126108 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 14986739 BACKGROUND

• 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.

  PMID: 32567415 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Margaret Doucette, D. O.

  Boise VAMC

  PRINCIPAL INVESTIGATOR

• Kattie B Payne, PhD, RN, MSN

  Boise VAMC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 17, 2015
• Study Start: May 30, 2015
• Primary Completion: August 31, 2019
• Study Completion: September 30, 2019
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)