Randomized, Prospective Controlled Head-to-head Clinical Trial Comparing a Bioengineered Skin Substitute to a Biologically Active Human Skin Allograft for the Treatment of Venous Leg Ulcers.

Summary

Given the propensity for venous leg ulcers to become refractory, long standing lesions, incorporating active biologic grafts into the standard compression therapy, has shown to accelerate wound healing. The two products to be compared in this study are both commonly used for the treatment of venous leg ulcers. Apligraf is considered a medical device by the FDA, and was cleared for the treatment of venous leg ulcers in 1998. It is a staple for the treatment of venous leg ulcers, and is widely used throughout the United States. It is composed of a type 1 collagen matrix in which human foreskin-derived neonatal fibroblasts are grown, and over which human foreskin-derived neonatal keratinocytes are then cultured and allowed to stratify. TheraSkin is composed of a split thickness skin graft harvested within 24 hours post-mortem, from an organ donor who has cleared the standard safety screenings. It is classified by the FDA as a donated tissue. Once harvested, the graft is sanitized according to FDA specifications, and cryopreserved, until it is delivered to the clinic for application to the foot ulcer. It is also a widely used treatment for diabetic foot ulcers. TREATMENT RATIONALE FOR THIS STUDY Chronic wounds of the lower extremities affect a substantial proportion of the population. Venous leg ulcers (VLU) account for 40-70% of lower extremity wounds. The standard of care for treatment of VLU's in wound centers in the United States is compression therapy combined with application of biologic graft materials to the wound bed. This study may assist physicians who treat VLU's by comparing efficacy and costs of two commonly used biologic graft materials for VLU's in a randomized prospective study. In addition to standard compression therapy, this investigation will be a head-to-head study comparing widely used bio-engineered skin substitute (Apligraf) to cryopreserved, human skin allograft (Theraskin). There is no randomized, prospective data comparing these two graft options in the treatment of VLU's.

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