FOOTSCAN IR THERMOMETRY & DIABETIC PATIENT SELF-CARE

足扫描红外测温

• 批准号: 6381252
• 负责人: KEVIN R HIGGINS
• 金额: $ 33.56万
• 依托单位: DIABETICA SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-30 至 2002-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6381252
• 关键词: amputation; biomedical equipment development; body temperature; clinical research; diabetes mellitus; diabetes mellitus therapy; diagnosis design /evaluation; diagnosis procedure safety; disease /disorder prevention /control; foot; home health care; human subject; human therapy evaluation; infrared radiation; outcomes research; self care; skin disorder diagnosis; skin ulcer; thermometry

Foot ulcers develop in diabetics with neuropathy because of cumulative injury over the course of several days. These patients do not feel pain, and do not recognize their foot is being injured until a wound develops. Areas about to ulcerate become inflamed and "hot spots" can be identified. This study's purpose is to evaluate the effectiveness of a home infrared temperature probe designed to forewarn patients that an area on the foot is inflamed so they can take preventive measures. The study will evaluate the incidence of diabetic foot ulcers among high-risk patients, evaluate the cost of home temperature monitoring compared to standard therapy, and evaluate patient satisfaction. 180 diabetics at high-risk of having foot complications will be randomized into 3 treatment arms: l) standard therapy consisting of regular foot care; 2) standard therapy plus recording of a structured foot evaluation using a hand mirror; and 3) standard therapy plus infrared home temperature assessment to identify "hot spots." Device patients will measure temperatures at 6 sites on the foot each day. When temperatures are elevated about 4 degrees F patients will contact the research nurse and decrease activity. The primary study outcome will be incident foot ulcers and Charcot fractures. PROPOSED COMMERCIAL APPLICATION: The FootScan dermal thermometry device promises to revolutionize patient self-care via a simple daily procedure of assessing one's foot temperatures in the home. This simple means will serve to decrease neuropathic ulcers, amputations and diabetic morbidity. In effect, the FootScan, should become the missing "early warning sign" for patients with sensory loss.

糖尿病合并神经病变的患者，由于数天的累积损伤，会出现足部溃疡。这些患者不会感到疼痛，并且直到伤口发展才意识到他们的脚受伤了。即将溃疡的区域会发炎，并且可以识别出“热点”。这项研究的目的是评估家用红外线温度探头的有效性，该探头旨在预先警告患者脚部某个区域发炎，以便他们采取预防措施。该研究将评估高风险患者中糖尿病足溃疡的发生率，评估家庭温度监测与标准治疗相比的成本，并评估患者满意度。将180名具有足部并发症高风险的糖尿病患者随机分为3个治疗组：1）由常规足部护理组成的标准治疗; 2）标准治疗加使用手镜记录结构化足部评估;和3）标准治疗加红外家庭温度评估以识别“热点"。“设备患者每天将测量足部6个部位的温度。当温度升高约4华氏度时，患者将联系研究护士并减少活动。主要研究结果将是发生足部溃疡和夏科骨折。拟定商业应用：FootScan皮肤温度测量设备承诺通过简单的日常程序评估一个人在家里的脚的温度，彻底改变病人的自我护理。这种简单的方法将有助于减少神经性溃疡、截肢和糖尿病发病率。实际上，足部扫描应该成为感觉丧失患者缺失的“早期预警信号”。