Diabetes Clinical Trial
— TempTouchRMOfficial title:
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.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | June 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Kevin R. Higgins, DPM | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Diabetica Solutions Inc. | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incident foot ulcers | one year | ||
Secondary | temperature spikes on foot zones | one year |
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