Cooling foot temperatures for diabetic neuropathy
Medical Need:
Diabetic foot ulceration has a complicated biomechanical pathology that involves not only plantar pressure but also shear stresses and physical activity, among other factors. A number of pressure ulcer studies have also demonstrated that warmer tissue is more vulnerable to breakdown when compared to cooler tissue.
Diabetic ulceration and related amputations impairs quality of life and also is incredibly costly to the patient and to the US healthcare system, costing an estimated $30 billion dollars annually. Although the etiology of diabetic foot ulcers is still debated, pressure, shear, and temperature are all thought to be contributing factors.
With Temperature and Pressure Monitoring and Regulating Insole (TAPMARI), Vivonics and our academic collaborators seek to develop new footwear that will monitor key biomarkers (pressure and temperature) that can report early tissue damage before it is clinically apparent and also counter pressure peaks and regulate temperature using a novel cooling/heating technology. This technology can later be utilized to assess the clinical efficacy of regulating temperature in preventing foot ulcers. Prior studies have shown that cooling the plantar surface can reduce skin breakdown and ulceration.
Availability of a system that can be worn for long periods of time and can monitor plantar temperature and pressure, reduce pressure peaks and control the plantar temperature will enable researchers to conduct in vivo studies to explore the efficacy of a widely accepted therapeutic method (i.e., hypothermia) in diabetic ulceration. In the future this tool may also be used as a prescribed therapeutic insole for the diabetic population.
Disclaimer: Research reported in this publication was supported by the National Institute Of Diabetes And Digestive And Kidney Diseases of the National Institutes of Health under Award Number R43DK109858. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
(Award R43DK109858 is titled: “Pressure and Temperature Monitoring and Regulating Insole”)
Product under development, not yet FDA approved