Over 15 percent of diabetic patients (DM) will experience a foot ulcer. Such patients must use special footwear for life to prevent recurrence. Currently the design and manufacture of therapeutic footwear is largely based on subjective criteria. Successful shoes are usually made by experienced craftspeople and many iterations are often required. We will, over both phases of the study, develop an entire therapeutic shoe system for at risk DM patients that will incorporate: data collection; automatic algorithm for insoles; CAD-CAM system for manufacture; and system for shoe selection including outsole modifications. Preliminary studies have provided experience and techniques for the analysis of in-shoe plantar pressure distribution, and market research has indicated that there is a need to provide a comprehensive footwear solution for this problem.
Two potentially competing CAD-CAM products are on the market to help physicians design custom footware for diabetic patients. Both are expensive, while DIApedia LLC will market its system for only between $5,000 and $10,000. The potential U.S. and European markets are each estimated to be more than $25 million: the Japanese market would be about half of this amount. The worldwide market potential is estimated to be over $65 million. The company will have an ongoing revenue stream from each pair of shoes that is produced.
