Novel Home Care Device for High-Risk Diabetic Patients

超过一半的下肢截肢是糖尿病患者。这些患者患有严重的， 糖尿病引起的周围、感觉神经病变，因此他们经常不能保护他们的脚免受反复发作 剪切力或创伤性发作和溃疡经常随之而来。我们之前已经证明了温度分布 足底方面的检查提供了可靠的组织损伤警告，并可有效地作为预防措施 情态。在这项研究中，我们计划进一步开发和临床测试一种新型的红外线体温仪。 (MedSkan)，专为高危糖尿病患者家庭使用。这套远程监控装置将服务于 作为即将发生的溃疡和夏科特骨折的早期预警系统。这是研究的中心！假设是 MedSkan设备将通过提供准确、简单和有效的监测方法来减少溃疡的发生率 足部温度的变化。为了研究这一假设，提出了以下具体目标： 目标1：开发、验证和执行下列软件和协议：(1)数据采集和处理， 以及(Ii)医生-MedSkan通信接口。将开发一种最先进的Web界面，以允许 临床医生可以查看其患者的存储数据。 目的2：评估MedSkan在降低高危人群糖尿病足溃疡发生率方面的有效性 病人。我们的假设是，接受MedSkan监测的患者脚部溃疡较少，溃疡将 不要那么严厉。110名患者的研究将包括两个治疗分支：标准治疗组和强化治疗组 治疗组，后者接受标准护理，外加每日使用MedSkan的红外体温监测，为期12天 月份。温度升高将向医生提供应该开始预防实践的信息， 如卸货、护肤等。 目的3：确定强化手术患者每只脚的正常体温变化范围。 并将偏离这一范围的偏差与溃疡的发生率联系起来。我们之前的研究使用了 以对侧足为对照，检测体温异常。我们将研究这样的假设，即有适当的 根据正常足温的趋势，单独的脚可以作为自己的控制来预测溃疡。 将注意遵守所有IRB和患者隐私法规。

More than half of all lower extremity amputations are in persons with diabetes. These patients suffer from severe, diabetes-induced, peripheral, sensory neuropathy and, thus they frequently do not protect their feet from repetitive shear stress or traumatic episodes and ulceration often ensues. We have previously shown that the temperature profile of the plantar aspects of the foot provides a reliable warning of tissue injury and can be effectively used as a preventive modality. In this study we propose to further develop and clinically test a novel infrared-based temperature instrument (MedSkan) that is intended for home use by high-risk diabetic patients. This step-on remote monitoring device will serve as an early warning system for impending ulcers and Charcot fractures. The study's centra! hypothesis is that the MedSkan device will reduce the incidence of ulcers by providing an accurate, simple, and effective approach to monitor changes in foot temperatures. To study this hypothesis, the following specific aims are proposed: Aim 1: To develop, validate and implement software and protocols for the following: (i) data acquisition and processing, and (ii) the physician-MedSkan communications interface. A state-of-the-art web interface will be developed to allow clinicians to view the stored data for their patients. Aim 2: To evaluate the effectiveness of the MedSkan in reducing the incidence of diabetic foot ulcers among high-risk patients. Our hypothesis is that patients monitored with the MedSkan will have fewer foot ulcers and that the ulcers will be less severe. The 110 patient study will comprise two treatment arms: the standard therapy group and the enhanced therapy group The latter will receive standard care plus infrared temperature monitoring using the MedSkan daily for 12 months. Elevated temperatures will provide information to the physician that prevention practices should be initiated, such as off-loading, skin care, etc. Aim 3: To determine the normal range of temperature variations for each individual foot for patients in the Enhanced Therapy and to correlate deviations from this range to the incidence of ulcers. Our previous studies have used the contralateral foot as the control to detect abnormal temperatures. We will investigate the hypothesis that with proper trending of normal foot temperatures, the individual foot can serve as its own control for predicting ulcers. Care will be taken to follow all IRB and patient privacy regulations.