FOOTSCAN IR THERMOMETRY & DIABETIC PATIENT SELF-CARE

有神经病变的糖尿病患者会发生足部溃疡，因为在几天的过程中会累积损伤。这些患者感觉不到疼痛，直到伤口形成时才意识到他们的脚受伤了。即将溃烂的区域会发炎，可以识别出“热点”。这项研究的目的是评估一种家用红外温度探测器的有效性，该探测器旨在预先警告患者脚上的一个区域发炎，以便他们采取预防措施。这项研究将评估高危患者中糖尿病足部溃疡的发生率，评估与标准治疗相比的家庭体温监测成本，并评估患者满意度。180名足部并发症的高危糖尿病患者将被随机分为3个治疗组：L)标准治疗，包括常规足部护理；2)标准治疗+使用手镜记录系统的足部评估；3)标准治疗+红外家庭温度评估，以确定“热点”。设备患者每天将在6个脚部部位测量体温。当温度升高时，大约4华氏度的患者会联系研究护士，减少活动量。主要的研究结果将是足部溃疡和夏科特骨折。拟议的商业应用：FootScan皮肤测温仪有望通过在家中评估一个人的脚温度的简单日常程序来彻底改变患者的自我护理。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，FootScan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.