FOOTSCAN IR THERMOMETRY & DIABETIC PATIENT SELF-CARE

足溃疡的发展与神经病变的糖尿病患者，因为累积损伤在几天的过程中。这些患者感觉不到疼痛，直到伤口形成才意识到他们的脚正在受伤。即将溃烂的部位会发炎，“热点”可以被识别出来。这项研究的目的是评估一种家用红外温度探头的有效性，该探头可以预先警告患者足部的某个区域发炎，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。180例有足部并发症的高危糖尿病患者将被随机分为3个治疗组：1)标准治疗包括常规足部护理；2)标准治疗加上用手镜记录结构化足部评估；3)标准疗法加上红外家居温度评估来识别“热点”。佩戴该设备的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。主要研究结果为足部溃疡和夏可骨折的发生率。拟议的商业应用：FootScan皮肤温度测量设备承诺通过一个简单的日常程序来评估一个人的足部温度，从而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、截肢和糖尿病的发病率。实际上，脚部扫描应该成为感觉丧失患者缺失的“早期预警信号”。

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.