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)
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.
DiagnosisWound must be less than 25cm but larger 1.0 cm.
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.
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.