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OpenTrials
Completed

NCT Number: NCT02632929

Prevention of Amputation in Diabetic Foot Ulcers Using 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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boise VAMC

Boise, Idaho, 83702, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Limb salvage

    Time frame: 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 outcomes

  1. effective wound healing

    Time frame: 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 outcomes

  1. Diabetic Foot Ulcer Quality of life Short Form survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boise VA Medical Center

Fed

Collaborators

  • Integra LifeSciences Corporation

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2015
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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