SBIR-STTR Award

We will fabricate and validate a home-based device (HealthScan) for diabetics at high risk for foot complications. This infrared step-on temperature instrument will serve as an early warning system for impending ulcers and Charcot fractures. The hypothesis is that the HealthScan device will provide an accurate and convenient approach to identify potential foot problems by monitoring dermal temperature changes on the plantar aspect of the foot. Aim 1. To fabricate and validate an infrared based version of the HeaithScan. First - Fabricate an infrared thermometry based HealthScan unit to measure the entire plantar aspect of the foot using a scanning technique. Second - To calibrate/validate the instrument using in vitro standards calibrated against NIST-traceable temperature probes using water baths held at various temperatures. Thereafter, we will verify accurate data transmission by the internal modem of the HealthScan. Aim 2. To examine in-clinic use of the HealthScan by diabetic patients. The HealthScan will be used in-clinic with 40 diabetic patients (20 with elevated temperatures and 20 with normal temperatures). Foot temperatures will be measured and then transmitted to a computer using the device's internal modem. Furthermore, the accuracy of the transmitted temperature data will be compared to a standard dermal thermometer.

Thesaurus Terms:
biomedical equipment development, decubitus ulcer, diabetes risk, diabetic neuropathy, diagnosis design /evaluation, foot, patient monitoring device, skin disorder diagnosis, thermometry home health care, joint disorder, noninvasive diagnosis, peripheral blood vessel disorder clinical research, human subject

More than half of all lower extremity amputations are in persons with diabetes. These patients suffer from severe, diabetes-induced, peripheral, sensory neuropathy and, thus they frequently do not protect their feet from repetitive shear stress or traumatic episodes and ulceration often ensues. We have previously shown that the temperature profile of the plantar aspects of the foot provides a reliable warning of tissue injury and can be effectively used as a preventive modality. In this study we propose to further develop and clinically test a novel infrared-based temperature instrument (MedSkan) that is intended for home use by high-risk diabetic patients. This step-on remote monitoring device will serve as an early warning system for impending ulcers and Charcot fractures. The study's central hypothesis is that the MedSkan device will reduce the incidence of ulcers by providing an accurate, simple, and effective approach to monitor changes in foot temperatures. To study this hypothesis, the following specific aims are proposed: Aim 1: To develop, validate and implement software and protocols for the following: (i) data acquisition and processing, and (ii) the physician-MedSkan communications interface. A state-of-the-art web interface will be developed to allow clinicians to view the stored data for their patients. Aim 2: To evaluate the effectiveness of the MedSkan in reducing the incidence of diabetic foot ulcers among high-risk patients. Our hypothesis is that patients monitored with the MedSkan will have fewer foot ulcers and that the ulcers will be less severe. The 110 patient study will comprise two treatment arms: the standard therapy group and the enhanced therapy group. The latter will receive standard care plus infrared temperature monitoring using the MedSkan daily for 12 months. Elevated temperatures will provide information to the physician that prevention practices should be initiated, such as off-loading, skin care, etc. Aim 3: To determine the normal range of temperature variations for each individual foot for patients in the Enhanced Therapy and to correlate deviations from this range to the incidence of ulcers. Our previous studies have used the contralateral foot as the control to detect abnormal temperatures. We will investigate the hypothesis that with proper trending of normal foot temperatures, the individual foot can serve as its own control for predicting ulcers. Care will be taken to follow all IRB and patient privacy regulations.

Thesaurus Terms:
Biomedical Equipment Development, Clinical Biomedical Equipment, Decubitus Ulcer, Diabetic Neuropathy, Diagnosis Design /Evaluation, Disease /Disorder Proneness /Risk, Foot, Patient Monitoring Device, Skin Disorder Diagnosis, Thermometry Body Temperature, Computer Program /Software, Computer System Design /Evaluation, Diagnostic Test, Disease /Disorder Prevention /Control, Early Diagnosis, Home Health Care, Joint Disorder, Noninvasive Diagnosis, Peripheral Blood Vessel Disorder Clinical Research, Human Subject, Patient Oriented Research