Clinical Trial

SkinTEâ„¢ in the Treatment of Diabetic Foot Wounds

Study Description

SkinTEâ„¢ in the Treatment of Diabetic Foot Wounds

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Human Autologous Homologous Skin Construct

Application of a autologous human derived skin polar units

Additional Outer Dressing Applicaiton

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

Offloading

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

Fibracol Wound Dressing

Application of Collagen Alginate Dressing

Additional Information

Official Study Title

A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effects of SkinTEâ„¢ in the Treatment of Wagner One Diabetic Foot Ulcers

Clinical Trial ID

NCT03881254

ParticipAid ID

e5yxAe