FOOTSCAN IR THERMOMETRY AND DIABETIC PATIENT SELF CARE

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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.