Novel Home Care Device for High-Risk Diabetic Patients
Status unconfirmed · Not applicable
Conditions studied: Diabetes, Neuropathic Limb, Elevated Temperature, Shear Pressure, Increased Temperatures
In brief
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.
Key facts
- Study ID
- NCT00500175
- Run by
- Diabetica Solutions Inc.
- People needed
- 110
- Starts
- 2007-01-01
- Expected to finish
- 2008-06-01
- Last updated by the study team
- 2007-07-12
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- diagnosis of diabetes by WHO criteria, ability to provide informed consent, 18-80 years of age.
You may not qualify if…
- 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.
Where it is running
- Kevin R. Higgins, DPM — San Antonio, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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