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. In this grant application, Vivonics and University of North Texas 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.
People with diabetes suffer from reduced circulation to the feet and may experience diabetic neuropathy that diminishes sensation from the foot, leaving the individual prone to developing foot ulcers that in some cases worsen and lead to amputation. While current therapeutic footwear attempts to address excess pressure on the foot, several studies have shown the causative effect of temperature on tissue breakdown, and studies in other branches of medicine have supported the use of decreased temperatures to preserve tissue health. In this program, we will develop special footwear that can monitor temperature and pressure, help avoid pressure peaks and control the temperature to cool the foot surface, to both detect and prevent conditions conducive to the formation of foot ulcers.
