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Prospective, Comparitive, Randomized Study of Allograft Versus Skin Substitute in Non-healing Diabetic Foot Ulcers

NCT02870816 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-12-08

No results posted yet for this study

Summary

The purpose of this study is to determine whether amnion membrane grafts are more effective than another tissue engineered skin substitute, when used to treat diabetic foot ulcers (DFUs).

Conditions

  • Diabetic Foot Ulcer

Interventions

PROCEDURE

Tissue Engineered Skin Substitute

Application of skin substitute and non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.

DEVICE

Offloading

Provision of offloading cast walker or similar sponsor-approved device. May convert into "instant total contact cast" and/or add felt/foam to supplement offloading.

PROCEDURE

Amnionic Membrane Graft

Application of amnion membrane graft and non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.

Sponsors & Collaborators

  • Musculoskeletal Transplant Foundation

    collaborator OTHER

  • Professional Education and Research Institute

    lead OTHER

Principal Investigators

  • Evangelia Chnari, PhD · Director of Research and Development; Wound Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-06-14
Completion
2018-06-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02870816 on ClinicalTrials.gov