In-Shoe Plantar Shear and Pressure Sensing System

描述（由申请人提供）：足部溃疡是一种糖尿病并发症，估计仅在美国每年就造成超过10亿美元的医疗费用。越来越多的证据表明，外力（压力和剪切）升高和组织特性改变的结合在足部溃疡的病因学中是最重要的。虽然测量足底压力的商业平台和鞋内系统在临床使用，但可以同时测量水平剪切和垂直压力的系统仍有待开发和商业化。所提出的研究的总体目标是开发一种多点鞋垫系统，该系统可以准确地表征足底表面的压力和剪切，薄而柔韧，足以对正常的脚-鞋相互作用提供最小的干扰，可以很容易地制造，并且可以进行足够的校准，用于研究和临床使用。

DESCRIPTION (provided by applicant): Foot ulceration is a diabetic complication estimated to result in over $1 billion worth of medical expenses per year in the United States alone. Increasing evidence indicates that a combination of elevated external forces (pressure and shear) and altered tissue properties is of prime importance in the etiology of foot ulcers. Although commercial platform and in-shoe systems to measure plantar pressure are in clinical use, a system that can measure both horizontal shear and vertical pressure remains to be developed and commercialized. The overall goal of the proposed research is to develop a multipoint, insole system that can accurately characterize both pressure and shear across the plantar surface, is thin and flexible enough to provide minimal interference with normal foot-shoe interaction, can be easily manufactured, and holds calibration sufficient for research and clinical use. In our Phase I program we will develop an array of 9 sensors with the accompanying electronics that can accurately measure applied normal pressure as high as 700 kPa and shear as high as 200 kPa. We will integrate this array into a single thin, flexible, compliant structure that will form the basis for a Phase II insole system and we will perform laboratory testing using two specially developed test fixtures to demonstrate sensor array performance against our success criteria for size, accuracy and stability of calibration. Success in Phase I will lead to full-scale implementation of an insole system with over 100 sensors in Phase II. We also plan in Phase II to integrate the system with software in development for visualization of foot pressure and shear data (1 R43 DK61164-01A1, Phase II award pending). The combined insole sensor and visualization software system would then be evaluated with data collected from both diabetic and normal patients. Commercial availability of a complete hardware and software analysis system to measure pressure and shear will greatly improve the diagnosis, prevention, and treatment of foot ulcers in diabetic patients.