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

这个小型企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是提供一类新的柔软，灵活，非磨损传感元件，提供精确的温度读数，对糖尿病患者的健康和流动性产生积极影响。这项研究的主要推动力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，导致两个重要和相关的结果。首先，他们有很高的风险，因为行走（摩擦）或站立（压力）产生的组织损伤会导致越来越多的未被发现的溃疡性损伤。第二，由于这些伤害是未被发现和感觉不到的，因此患者寻求医疗护理的紧迫性降低。医疗干预的延误进一步加剧了伤害，使治疗复杂化，导致与足部溃疡相关的经济负担，估计每年为150亿美元。更重要的是，首次溃疡后的5年死亡率（40%）接近心力衰竭的死亡率（50%）。一个简单的和具有成本效益的预防溃疡的范例的关键需要是一个安全的，易于使用的足部监测系统，具有温度传感能力与远程读出。拟议的项目利用一种创新的方法来开发一个非侵入性传感系统，将提供不断监测皮肤温度的能力，将集成到一个糖尿病友好鞋垫。皮肤温度已被证明是足部溃疡发展的预测指标，并且还可以用作伤口愈合的测量。一个简单的系统能够早期检测即将发生的皮肤溃疡，从而减少进一步的组织损伤，减少截肢，节省财政，医疗和情感资源。该概念验证鞋内衬被设计为每天驻留在患者的鞋中，以连续记录患者的足部健康。此外，该软件系统，包括一个移动的应用程序的用户以及一个医生仪表板，开发作为一个沟通渠道之间的病人，医疗保健提供者和护理人员。这个奖项反映了NSF的法定使命，并已被认为是值得支持的评估使用基金会的智力价值和更广泛的影响审查标准。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to provide a new class of soft, flexible, nonabrasive sensing elements which provides 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 that would be integrated into a diabetic-friendly insole. 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 shoe insert is designed to reside daily in a patient's shoes to continuously record the patient's foot health. In addition, the software system, including a mobile app for users as well as a doctor dashboard, is developed as a communication channel between the patient, the healthcare provider and the caregiver.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.