Progression of diabetic foot ulcers is the leading cause of lower limb amputations in the U.S. More than 800,000 foot ulcers are treated annually with progression to more than 86,000 amputations each year. Between 1/4 to 1/2 of the $ 27.3 billion in direct diabetes in-patient medical expenses is used for the treatment of foot ulcers. There is clearly a significant unmet medical need for a cost-effective, efficacious treatment for diabetic foot ulcers. The long-term goal of this project is to provide a novel treatment for diabetic foot ulcers, E-Matrix (TM). E-Matrix (TM) is a bioactive hydrogel designed to mimic the open polar structure seen in early fetal development. Treatment of chronic wounds in pre-clinical studies and in a 6 patient feasibility study demonstrated its ability to stimulate healing of chronic ulcers. This project will further support the commercial development of E-Matrix (TM).
The Specific Aims of this project are to: (1) demonstrate the safety and efficacy of E-Matrix (TM) for the treatment of diabetic foot ulcers in a 60 patient randomized, controlled Pilot Clinical study; (2) develop validated physical-chemical analytical methods to characterize the raw material components and fully formulated E-Matrix (TM) and link these properties to its biological activity; and (3) determine E-Matrix (TM) effects on specific gene activity important for the healing of chronic wounds using in vitro cell models and analysis of clinical tissue samples. The clinical study will examine the effect of up to 4 E-Matrix (TM) injections on ulcer healing during 84 days of follow-up with a 6 month examination to determine if healed ulcers remain closed. The physical-chemical analysis will use FTIR and SEC-MALLS to determine the extent and nature of interactions within the co-polymer and rheology to examine the physical properties of E-Matrix (TM) . Gene expression studies will use real-time PCR to quantify changes in relevant gene expression. Completion of these studies will provide the basis for the next important step in the commercial development of the E-Matrix (TM), submission and approval by FDA of a Pivotal Trial for diabetic foot ulcers. Successful completion of the Pivotal Trial will ultimately result in submission and approval of a PMA for E-Matrix (TM) treatment of diabetic foot ulcers.
