Novel Home Care Device for High-Risk Diabetic Patients

针对高危糖尿病患者的新型家庭护理设备

• 批准号: 7258424
• 负责人: KEVIN R HIGGINS
• 金额: $ 24.02万
• 依托单位: DIABETICA SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7258424
• 关键词: Address; Amputation; Arts; Attention; Attenuated; Caring; Clinic Visits; Clinical; Clinical Trials; Communication; Computer Analysis; Computer software; Computers; Contralateral; Control Groups; Daily; Data; Data Element; Databases; Dermal; Devices; Diabetes Mellitus; Diabetic Foot Ulcer; Effectiveness; Environment; Evaluation; Exhibits; Foot Ulcer; Fracture; Health Insurance Portability and Accountability Act; Health Personnel; Home environment; Incidence; Individual; Inflammation; Injury; Intuition; Leg; Legal patent; Life; Limb structure; Lower Extremity; Measurement; Measures; Medicine; Modality; Modems; Monitor; Normal Range; Nurses; Outcome; Pain; Pathology; Patient Monitoring; Patients; Persons; Phase; Phase I Clinical Trials; Physical Examination; Physicians; Prevention; Preventive; Primary Care Physician; Privacy; Process; Protocols documentation; Purpose; Range; Reading; Redness; Regulation; Reporting; Research Ethics Committees; Research Personnel; Risk; Security; Site; Skin Care; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Standards of Weights and Measures; Structure; Surface; Swelling; System; Systems Analysis; Techniques; Telephone; Temperature; Testing; Therapeutic; Time; Tissues; Ulcer; Update; Upper arm; Validation; Variant; Visual; Week; Work; analog; base; compare effectiveness; compliance behavior; data acquisition; day; design; diabetic; experience; foot; improved; instrument; monitoring device; novel; patient home care; patient privacy; prevent; programs; prototype; sensory neuropathy; shear stress; transmission process; trend; web interface

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.

超过一半的下肢截肢患者患有糖尿病。这些患者患有严重的， 糖尿病引起的周围感觉神经病变，因此它们经常不能保护他们的脚免受重复性的 剪切应力或创伤性发作和溃疡经常伴随。我们之前已经证明，温度分布 提供了组织损伤的可靠警告， 模态在这项研究中，我们建议进一步开发和临床测试一种新的红外线温度仪器 （MedSkan），旨在供高风险糖尿病患者家庭使用。这个远程监控装置将用于 作为即将发生的溃疡和夏科骨折的早期预警系统。书房中央！假设是 MedSkan设备将通过提供准确、简单和有效的监测方法来降低溃疡的发生率 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、验证和实施用于以下方面的软件和协议：㈠数据采集和处理， 和（ii）医生-MedSkan通信接口。将开发一个最先进的网络界面， 临床医生查看其患者的存储数据。 目的2：评价MedSkan在降低高危人群糖尿病足溃疡发生率方面的有效性 患者我们的假设是，使用MedSkan监测的患者足部溃疡较少， 不那么严重。110例患者的研究将包括两个治疗组：标准治疗组和增强治疗组。 治疗组：后者将接受标准护理，并使用MedSkan每天进行红外体温监测，持续12 个月升高的温度将为医生提供信息，即应开始预防措施， 如减肥、护肤等。 目的3：确定增强型患者每只脚的温度变化的正常范围 治疗，并将偏离该范围与溃疡发生率相关联。我们以前的研究使用了 以对侧足为对照，检测体温异常。我们将研究这样的假设：在适当的情况下， 根据正常足部温度的趋势，单个足部可以作为预测溃疡的自身对照。 应注意遵守所有IRB和患者隐私法规。