This Phase II SBIR proposal describes a strategy and work plan for accelerating to market a new device that will provide an evidence-based, patient-specific solution to a significant public health problem: foot pain. The TrueContour(R) therapeutic insole system was originally conceived for prevention of forefoot injury in diabetes mellitus. We propose to further develop and extend the applicability of the core elements of the TrueContour(R) system to provide advanced foot orthotics for two other clinically important areas: rheumatoid arthritis/forefoot pain and plantar fasciitis/heel pain. The application of the TrueContour(R) technology to address other common foot complaints will complement the existing diabetic product and offer foot professionals a comprehensive solution for the design and fabrication of custom foot orthotics. This extension will not only address a broader range of clinically important foot problems for which current solutions are often inadequate, but will also provide the opportunity for successful commercialization of a system that is poised to fill a significant unmet medical need. Furthermore, this will be the only system in the marketplace for which an evidence base exists in the refereed literature. Our work plan will employ a proven scientific approach for orthotic design and validation to achieve the following: Phase II Objectives: A) Complete the development of the TrueContour(R)RA foot orthotics for relief of forefoot pain caused by RA. B) Complete the development of the TrueContour(R)PF foot orthotics for relief of heel pain caused by PF. C) Validate the efficacy of the TrueContour(R)RA foot orthotics through clinical testing. D) Validate the efficacy of the TrueContour(R)PF foot orthotics through clinical testing. E) Install the expanded TrueContour(R) therapeutic insole system in high-volume clinics beta sites;refine and optimize usability of the system based upon practitioner and patient feedback.
DIApedia, LLC has developed and scientifically validated a system for the design and production of therapeutic insoles for diabetic patients, the TrueContour(R) therapeutic insole system. In this SBIR proposal we aim to further develop and extend the applicability of the core elements of the TrueContour(R) system to provide advanced foot orthotics for two other clinically important areas: forefoot pain due to rheumatoid arthritis (RA) and heel pain due to plantar fasciitis (PF).
