Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue

Diabetic Foot Ulcer Clinical Trial

Official title:

Prevention of Amputation in a High Risk Population With Comprehensive Care and Amniotic Tissue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632929
• Other study ID #: 00816
• Status: Completed
• Start date: May 30, 2015
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2023
• Source: Boise VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Locations

Country	Name	City	State
United States	Boise VAMC	Boise	Idaho

Sponsors (2)

Lead Sponsor	Collaborator
Boise VA Medical Center	Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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