Clinical trial NCT02632929: Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue
Official title: Prevention of Amputation in a High Risk Population With Comprehensive Care and Amniotic Tissue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer
Keywords: foot ulcer, diabetic
wound healing
diabetic foot ulcer
Lead sponsor: Boise VA Medical Center
Sponsor class: FED
Collaborators: name: Integra LifeSciences Corporation
First posted: 2015-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Limb salvage
timeFrame: One month past wound healing
Secondary outcomes:
measure: effective wound healing
timeFrame: One month past wound healing
Other outcomes:
measure: Diabetic Foot Ulcer Quality of life Short Form survey
timeFrame: Comparison of patient's perception at enrollment, wound heal, one month, and 2-4 months after the wound is healed.
Locations:
city: Boise
country: United States
facility: Boise VAMC
state: Idaho
Study officials:
affiliation: Boise VAMC
name: Margaret Doucette, D. O.
role: PRINCIPAL_INVESTIGATOR
affiliation: Boise VAMC
name: Kattie B Payne, PhD, RN, MSN
role: STUDY_DIRECTOR
References:
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.
citation: 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
citation: 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.
citation: 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.