Novel Home Care Device for High-Risk Diabetic Patients
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Diabetes |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | January 2007 |
| End Date: | June 2008 |
| Contact: | Kevin R HIggins, DPM |
| Email: | higgins@xilas.com |
| Phone: | (210) 657-2644 |
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.
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.
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.
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