FOOTSCAN IR THERMOMETRY AND DIABETIC PATIENT SELF CARE

FOOTSCAN 红外测温和糖尿病患者自我护理

• 批准号: 2713541
• 负责人: KEVIN R HIGGINS
• 金额: $ 10万
• 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 1999-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2713541
• 关键词: biomedical equipment development; clinical research; clinical trials; 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

To evaluate the effectiveness of the FootScan, a novel infrared skin temperature assessment device, on clinical outcomes, functional status and patient satisfaction in diabetics at high risk for foot ulceration. Salix Medical will enroll 82 patients (41 per arm) in a single-blinded randomized clinical trial to evaluate the morbidity, functional status, and patient satisfaction of infrared dermal thermometry when used at home by half of the patient population. Patients using the FootScan device will be compared to a control group not receiving daily self- thermometric evaluation. When skin temperature is elevated by more than four degrees Fahrenheit compared to the opposite foot, patients will be instructed to contact the study coordinator and to decrease their activity. During the course of study, the treating clinician will be blinded as to whether the patient belongs to the thermometry or control group. The clinical outcomes will include incident foot ulcers, infections and amputations. Salix Medical anticipates that fewer patients will ulcerate, become infected and require amputations when performing daily home dermal thermometry. The FootScan device has the potential of being, much like the glucometer, a commodity home use product. It could significantly reduce morbidity and health care costs while increasing patients' quality of life. PROPOSED COMMERCIAL APPLICATION: The low cost 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 morbidities. In effect, the FootScan, should become the missing "early warning sign" for patients, with sensory loss.

为了评估FootScan的有效性， 温度评估器械，临床结局，功能状态 和患者满意度的影响。 Salix Medical将入组82例患者（每组41例）， 随机临床试验，以评估发病率，功能状态， 和患者满意度的红外皮肤测温法时， 一半的病人都在家里。使用FootScan的患者 将器械与未接受每日自我治疗的对照组进行比较， 测温评价 当皮肤温度升高超过 与另一只脚相比， 指示联系研究协调员并减少其 活动在研究过程中，治疗临床医生将 对患者是否属于测温组或对照组设盲 组 临床结果将包括足部溃疡事件， 感染和截肢。 Salix Medical预计，更少的患者会溃疡， 感染并需要截肢时，进行日常家庭皮肤 温度测定法 FootScan设备有可能成为， 血糖仪，一种家用商品。能明显 降低发病率和医疗保健成本，同时增加患者的 生活质量 拟定商业应用： 低成本的FootScan皮肤温度测量设备承诺， 通过简单的日常程序彻底改变患者的自我护理， 在家里测量脚部温度。 这种简单的方法将 有助于减少神经性溃疡，截肢和糖尿病 病态 实际上，FootScan应该成为失踪的“早期”， 警告标志”的病人，与感官丧失。