Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02632929

Enrollment

Registered

2015-12-17

Start date

2015-05-30

Completion date

2019-09-30

Last updated

2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer

Keywords

foot ulcer, diabetic, wound healing, diabetic foot ulcer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Limb salvage	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

Measure	Time frame	Description
effective wound healing	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

Other

Measure	Time frame	Description
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.	Quality of life measured at enrollment in study, at wound healed, one month post-healed, and 2-4 months later.

Countries

United States

Outcome results