DIAPEDIA, LLC — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): DIApedia, LLC has developed and scientifically valid

Description

DESCRIPTION (provided by applicant): 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). The Phase I studies proposed here will be proof of concept for these two problems. The application of the TrueContour(R) technology to address other common foot complaints will complement the existing diabetic product and offer foot professionalsa 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. If our Phase I efforts are successful, the expanded product offering would be rigorously evaluated through internal experimentation, independent validation with research collaborators and beta testing by professionals in the podiatric, rheumatologic, and orthopedic fields - under a Phase II proposal. Specific Aims: A) Pilot-test a line of foot orthotics which incorporates patient-specific plantar pressure measurements in the design of interventions aimed at reducing forefoot pain for people with rheumatoid arthritis. B) Pilot-test a line of foot orthotics which incorporates patient-specific plantar pressure measurements in the design of interventions aimed at reducing pain for people with heel pain due to plantar fasciitis. Successful execution of the Phase I plan will enable DIApedia to accomplish the following milestones: 1. In patients with RA and forefoot pain, a forefoot threshold pressure contourand intervention geometry and material characteristics will be suggested by iterative experiments such that interventions (bars, pads, reliefs) based on these characteristics will provide pain relief. 2. In patients with PF and heel pain, a heel thresholdpressure contour and intervention geometry and material characteristics will be suggested by iterative experiments such that interventions based on these characteristics will provide pain relief. PUBLIC HEALTH RELEVANCE: DIApedia, LLC has developedand 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).