The supplement features a discussion on available clinical evidence from trials conducted in patients with diabetic foot ulcers (DFUs). The authors, Dr. Lawrence Lavery, Professor of Surgery, University of Texas Southwestern and Dot Weir, RN, CWON, CWS, assign a high-quality, successful designation to only 4 trials in the space including Grafix, Dermagraft, Apligraf, and Graftjacket as these are the only trials that were multi-center, randomized, controlled trials.
Furthermore, the authors note that Grafix is the only placental membrane product for chronic wounds supported by multicenter, randomized, controlled, clinical evidence.
The supplement describes the explosion of products in the wound care market including bioengineered tissue, skin substitutes, cellular and acellular dermal matrix products. The supplement also illustrates how various processing methods impact the structure and overall functionality of the product.
The expert panel concluded that only the cryopreserved process maintains the structure and functionality of natural tissue including tissue architecture, three-dimensional extracellular matrix, growth factors and cellular outgrowth. Grafix, through Osiris’ proprietary BioSmart manufacturing process, is the only cryopreserved placental membrane that maintains the placental tissue in its most natural state.
Protocol 302 is a single-blind, randomized, controlled multi-centered trial evaluating the efficacy and safety of weekly applications of Grafix for the treatment of chronic diabetic foot ulcers. A total of 97 patients were enrolled at 20 leading wound care centers across the United States.
Patients between 18 and 80 years of age with confirmed type 1 or type 2 diabetes and chronic diabetic foot ulcers on the dorsal or plantar surface of the foot were randomized to Grafix or control at a 1:1 ratio. Ulcers had to be present for at least 4 weeks prior to randomization and be between 1 cm2 and 15 cm2 in size. Patients were excluded from the trial if the ulcer decreased with more than 30% during the one week screening period. Patients received treatment weekly for up to 12 weeks.
The primary endpoint measures complete wound closure by 12 weeks as determined by the investigator and confirmed by an independent, blinded Wound Core Lab. Secondary endpoints include complete wound closure rates for those patients that complete all scheduled treatments, time to wound closure, number of applications and adverse events, including reduction in infections. Patients randomized to control, who did not heal within 12 weeks, entered a cross-over arm for evaluation in an additional 12 week open-label treatment with Grafix.
Grafix is a cryopreserved placental membrane for acute and chronic wounds. It is a flexible, conforming membrane that is applied directly at the site of the wound. Grafix is produced by Osiris’ BioSmartTM Intelligent Tissue Processing which maintains the integrity of the extracellular matrix, growth factors, and endogenous fibroblasts, epithelial cells and mesenchymal stem cells of the native tissue.