2 Clinical Trials for Various Conditions
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.
This is a pilot, open-label, and single-center, single-treatment prospective evaluation of the electrocoagulation of axillary sweat gland tissue using the ThermiRF device to improve excessive sweating of the axilla(s). In this study, "Temporary Relief" is defined as improvement on the DLQI. Twenty male and female subjects between 18 and 50 years old will be enrolled. A total of five visits are planned for this study. A punch biopsy will be collected (prior to and post treatment and analyzed to determine the degree of impact to the tissue after the electrocoagulation treatment. Safety assessments will be collected using the Numerical Rating Scale (NRS) a 10-point scale, and adverse events reports (observed or reported). The total length of the study is approximately 4 months.