Pressure and Temperature Monitoring and Regulating Insole

项目总结/摘要 糖尿病足溃疡具有复杂的生物力学病理学，其不仅涉及足底压力， 以及剪切应力和身体活动等因素。一些压力性溃疡的研究也 证明了与较冷的组织相比，较热的组织更容易破裂。糖尿病 溃疡和相关的截肢损害了生活质量，并且对患者和美国来说也是难以置信的昂贵 医疗保健系统，估计每年花费300亿美元。虽然糖尿病足溃疡的病因 尽管仍有争议，但压力、剪切力和温度都被认为是影响因素。 在这项拨款申请中，Vivonics和北德克萨斯大学寻求开发新的鞋类， 关键生物标志物（压力和温度），可以在临床表现明显之前报告早期组织损伤 并且还使用新颖的冷却/加热技术来对抗压力峰值并调节温度。这 这项技术可以用来评估调节温度在预防足部溃疡方面的临床效果。 先前的研究表明，冷却足底表面可以减少皮肤破裂和溃疡。 能够长时间佩戴并且能够监测足底温度的系统的可用性， 压力，降低压力峰值和控制足底温度将使研究人员能够在体内进行 探索广泛接受的治疗方法的功效的研究（即，低体温）。 在未来，这种工具也可以用作糖尿病人群的处方治疗鞋垫。

PROJECT SUMMARY/ABSTRACT Diabetic foot ulceration has a complicated biomechanical pathology that involves not only plantar pressure but also shear stresses and physical activity, among other factors. A number of pressure ulcer studies have also demonstrated that warmer tissue is more vulnerable to breakdown when compared to cooler tissue. Diabetic ulceration and related amputations impairs quality of life and also is incredibly costly to the patient and to the US healthcare system, costing an estimated $30 billion dollars annually. Although the etiology of diabetic foot ulcers is still debated, pressure, shear, and temperature are all thought to be contributing factors. In this grant application, Vivonics and University of North Texas seek to develop new footwear that will monitor key biomarkers (pressure and temperature) that can report early tissue damage before it is clinically apparent and also counter pressure peaks and regulate temperature using a novel cooling/heating technology. This technology can later be utilized to assess the clinical efficacy of regulating temperature in preventing foot ulcers. Prior studies have shown that cooling the plantar surface can reduce skin breakdown and ulceration. Availability of a system that can be worn for long periods of time and can monitor plantar temperature and pressure, reduce pressure peaks and control the plantar temperature will enable researchers to conduct in vivo studies to explore the efficacy of a widely accepted therapeutic method (i.e., hypothermia) in diabetic ulceration. In the future this tool may also be used as a prescribed therapeutic insole for the diabetic population.