SBIR Phase I: Conformal Temperature Sensors for Remote Monitoring of Diabetic Ulceration

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是提供一种新型的柔软、灵活、非研磨性的传感元件，提供精确的温度读数，对糖尿病患者的健康和移动性产生积极影响。这项研究的主要动机是主要关注患有足部神经损伤的晚期糖尿病患者。这些患者感觉不到他们的脚，导致了两个重要的相关结果。首先，由于行走(摩擦)或站立(压力)造成的组织损伤，他们有更多未被发现的溃疡损伤的风险。其次，由于这些损伤没有被发现，也没有感觉到，患者寻求医疗护理的紧迫性降低了。医疗干预的拖延进一步加剧了伤害，使治疗复杂化，导致与足部溃疡相关的经济负担，估计每年高达150亿美元。更重要的是，首次溃疡后5年的死亡率(40%)接近心力衰竭的死亡率(50%)。对简单且经济实惠的溃疡预防范例的关键需要是一种安全、易于使用的足部监测系统，该系统具有远程读数的温度传感功能。拟议的项目利用一种创新的方法来开发一种非侵入性传感系统，该系统将提供持续监测皮肤温度的能力。皮肤温度已被证明是足部溃疡发展的预测指标，还可以作为伤口愈合的衡量标准。一个简单的系统能够及早发现迫在眉睫的皮肤溃疡，从而减少进一步的组织损伤，减少肢体截肢，并节省经济、医疗和情感资源。概念验证传感器被设计成每天驻留在患者的S鞋中，在患者经历破坏性活动(如行走或站立)时记录温度，提醒患者即将发生的组织损伤。该传感器还可以每天安装在患者S的医疗石膏中，提供指示组织愈合的恒定皮温读数，允许门诊监测，减少重复前往医疗机构进行检查。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to provide a new class of soft, flexible, nonabrasive sensing elements which provide precise temperature readings to positively impact the health and mobility of diabetic patients. The principle impetus of this research is to focus primarily on advanced diabetic patients who suffer from nerve damage to their feet. These patients cannot feel their feet, leading to two important and related results. First, they are at high risk for an increased number of undetected ulcerating injuries from tissue damage produced by walking (friction) or standing (pressure). Second, since these injuries are undetected and unfelt, there is a decreased urgency by the patient to seek medical care. Delays in medical intervention further exacerbate injuries and complicate treatment, leading to an economic burden associated with foot ulceration estimated at $15 billion annually. More importantly, the 5-year mortality rate after first ulceration (40%) approaches mortality rates from heart failure (50%). The key need for a simple and cost-effective ulcer-prevention paradigm is a safe, easy-to-use foot monitoring system with temperature-sensing capability with a remote readout. The proposed project utilizes an innovative approach to develop a non-invasive sensing system that will provide the ability to constantly monitor skin temperature. Skin temperature has been shown to be a predictive indicator of foot-ulcer development and can additionally be used as a measure of wound healing. A simple system enabling early detection of imminent skin ulceration subsequently reduces further tissue damage, decreasing limb amputations and saving financial, medical and emotional resources. The proof of concept sensor is designed to reside daily in a patient?s shoe to record temperatures while the patient experiences damaging activity such as walking or standing, alerting the patient to impending tissue injury. The sensor can also reside daily in a patient?s medical-treatment cast, providing a constant readout of skin temperature indicating tissue healing, allowing for out-patient monitoring and decreasing repeated visits to medical facilities for checkups.