This proposal describes a two-year plan to test the efficacy of a device that simulates the protective sensation lost to neuropathy. The Neuropathic Foot Protection System (NFPS) is a portable sensory feedback system designed to aid in the prevention of diabetic foot ulcers. Elevated foot pressure, in the presence of neuropathy, is a known component cause of 84% of diabetic lower extremity amputations. The NFPS increases user awareness of peak foot pressures generated during walking and may interrupt the pathway to ulcer formation. Primary Phase II research activities include: 1) device refinement and production, 2) protocol training, and 3) clinical trials. Patients diagnosed with distal neuropathy will participate in year long clinical trials at established diabetic foot research clinics at three VA medical Centers. The capacity and degree to which the NFPS users learn protective motor skills will be determined by tracking changes in plantar pressure distribution and adaptation. These measures will be correlated to changes in foot status. Presently, patient education and custom footwear are the most effective means of combating ulcers. However, the need to improve prevention is evidenced by an annual 6% growth of cases and costs in the US alone.
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