NCT02870816View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

June 14, 2018

Study Completion Date

June 14, 2018

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.

Trial Locations (3)

24013

Shenandoah Lower Extremity Research Institute, Roanoke

24016

Professional Education and Research Institute, Roanoke

24112

Martinsville Research Institute, Martinsville

Sponsors
All Listed Sponsors
collaborator

Musculoskeletal Transplant Foundation

OTHER

lead

Professional Education and Research Institute

OTHER