Novel Home Care Device for High-Risk Diabetic Patients
Novel Home Care Device for High-Risk Diabetic Patients
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 (TempTouchRM®) 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 TempTouchRM device will reduce the incidence of ulcers by providing an accurate,
 simple, and effective approach to monitor changes in foot temperatures.
The study's central hypothesis is that the TempTouchRM 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-TempTouchRM 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 TempTouchRM in reducing the incidence of diabetic
 foot ulcers among high-risk patients. Our hypothesis is that patients monitored with the
 TempTouchRM 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 TempTouchRM 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.
Inclusion Criteria:

 -  diagnosis of diabetes by WHO criteria, ability to provide informed consent, 18-80
 years of age.

 Exclusion Criteria:

 -  patients with open ulcers or open amputation sites, active Charcot arthropathy, severe
 peripheral vascular disease, active foot infection, dementia, impaired cognitive
 function, history of drug or alcohol abuse within one year of the study, or other
 conditions based on the PI's clinical judgment.