SBIR-STTR Award

Diabetic patients with peripheral sensory neuropathy are at high risk for the development of foot ulcerations. These ulcerations remain unnoticed in the absence of pain or "protective sensation" and often develop into secondary infection(s) that can lead to amputation. Fifty to seventy percent of all lower extremity amputations are performed on patients with diabetes where distal neuropathy is considered a component cause. Despite repeated warnings to modify weight bearing habits, these patients will often ambulate without significant change that enables healing of lesions or wounds. Since partial or complete insensitivity to pain is central to all forms of diabetic foot ulcerations, a method of providing "protective sensation" could serve to regulate activities that may complicate these kind of foot problems. This research will investigate the effect of a neuropathic foot protection system (NFPS) that provides sensation to a patient that is based on plantar pressure patterns. Repeated clinical trials will measure the changes in foot pressure distribution and kinematic gait parameters that result from the NFPS intervention. Positive results of this investigation could potentially form a basis for incorporating the NFPS in treatment plans for the estimated 3 million people in the US with foot problems related to diabetes.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.