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RESTRATA

Trial Overview

Official Title

Assessment of Wound Closure Comparing Synthetic Hybrid-
Scale Fiber Matrix with Lyophilized Acellular Fish Skin in
Treating Diabetic Foot Ulcers (DFU) and with Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)

Study Purpose

The purpose of the following prospective study is to compare synthetic hybrid-scale fiber matrix with lyophilized acellular fish skin in treating diabetic foot ulcers in human subjects, and to compare synthetic hybrid-scale fiber matrix with living cellular skin substitute in treating venous leg ulcers.

Diagnosis

Wound must be less than 25cm but larger 1.0 cm.

Eligibility

Ulcer must be present more than 28 days prior to randomization. 
Patients cannot be pregnant, plan to become pregnant, or be breast feeding. Patients cannot have a known allergy to bovine or agarose materials. HA1C cannot be about 12. Patient cannot have active cancer or current/chronic use of corticosteroids.

Intervention

Site will only be enrolled for Venous Leg Ulcer arm of study comparing living cellular skin substitute (Apligraf®) to synthetic hybrid-scale fibermMatrix (Restrata®)

For more information, visit clinicaltrials.gov.

Key Participation Requirements
Trial Location(s)
Gender
All
Age
18 and older
Enrollment Status
Available
Phase
Phase IV
Methodist Health System Trial Code
NCT04927702