Bioactive Split Thickness Skin Allograft Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 6, 2019

Primary Completion Date

September 14, 2021

Study Completion Date

October 1, 2021

Conditions
Diabetic FootUlcer Foot
Interventions
OTHER

Human split thickness skin allograft

Application of a fenestrated human skin graft

OTHER

Additional Outer Dressing Applicaiton

Application of Moisture retentive dressing, and a multi-layer compression dressing

OTHER

Offloading

Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot

OTHER

Fibracol Wound Dressing

Application of Collagen Alginate Dressing

Trial Locations (5)

23116

Martinsville Research Institute, Martinsville

24153

Foot and Ankle Associates of Southwest VA, Salem

44512

Lower Extremity Institute of Research and Therapy, Youngstown

62269

Gateway Clinical Trials LLC, O'Fallon

94115

Center for Clinical Research, San Francisco

All Listed Sponsors
collaborator

Solsys Medical LLC

INDUSTRY

lead

Professional Education and Research Institute

OTHER

NCT04040426 - Bioactive Split Thickness Skin Allograft Versus Standard of Care in the Treatment of Diabetic Foot Ulcers | Biotech Hunter | Biotech Hunter