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

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byRobert Galiano, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Professional Education and Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data as well as assess performance and safety of a commercially available human split thickness skin allograft with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds.

Research Team

David Armstrong, DPM, MD, PhD

Principal Investigator

USC Keck School of Medicine - Salsa

Robert Galiano, MD

Principal Investigator

Northwestern University

Eligibility Criteria

Inclusion Criteria

At least 18 years old.

Presence of a DFU, Wagner Grade 1 (see Appendix A for definitions), extending at least through the dermis provided it is below the medial aspect of the malleolus.

The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.

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Treatment Details

Interventions

Human split thickness skin allograft (Skin Allograft)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Human split thickness skin allograft (Theraskin™)Experimental Treatment3 Interventions

Theraskin™ is an all-human split thickness skin allograft with a native extracellular matrix that can be used an adjunct to standard of care, for skin coverage in patients who have suffered from a diabetic foot wound in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing. Theraskin™ is an allograft tissue and will be used in compliance with homologous use by the FDA under section 361 of the PHS Act and 21 CFR Part 1271

Group II: Fibracol wound dressingActive Control3 Interventions

A commercially available wound dressing to be used per manufacturer's instructions for use on diabetic foot wounds in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing moisture retention dressing