Novel Home Care Device for High-Risk Diabetic Patients

描述(由申请人提供)： 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重复剪切力或创伤性发作的影响，并经常接踵而至的溃疡。我们以前已经证明，足底部位的温度分布提供了可靠的组织损伤警告，可以有效地用作预防措施。在这项研究中，我们建议进一步开发和临床测试一种新型的基于红外的体温仪器(MedSkan)，该仪器适用于高危糖尿病患者的家庭使用。这种阶梯式远程监测设备将作为即将发生的溃疡和Charcot骨折的早期预警系统。这项研究的中心假设是，MedSkan设备将通过提供一种准确、简单和有效的方法来监测足部温度的变化，从而降低溃疡的发生率。为了研究这一假设，提出了以下具体目标：目标1：开发、验证和实施以下软件和协议：(I)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网络界面，使临床医生能够查看他们患者的存储数据。目的：评价MedSkan在降低高危患者糖尿病足溃疡发生率方面的效果。我们的假设是，接受MedSkan监测的患者脚部溃疡较少，溃疡也不那么严重。这项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。后者将接受标准护理，并在12个月内每天使用MedSkan进行红外温度监测。温度升高将向医生提供应开始预防措施的信息，如卸载、皮肤护理等。目标3：确定增强疗法中患者每只脚温度变化的正常范围，并将偏离该范围的范围与溃疡发生率关联起来。我们以前的研究使用对侧足作为对照来检测异常温度。我们将研究这样一种假设，即通过正常足部温度的适当趋势，个体足部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。

DESCRIPTION (provided by applicant): 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 central 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.