Temperature Regulating Shoes for Prevention of Diabetic Foot Ulcers

Diabetic foot ulcers (DFU) continue to burden Americans with over 100,000 amputations every year. We believe that better understanding of the etiology and a multi-factorial approach that combines in-shoe temperature regulation along with plantar stress reduction could dramatically improve this outcome. Previous research indicated that soft tissue is prone to ulceration at warmer temperatures. Likewise, animal studies indicate higher tissue resistance to break-down when cooled to 25 °C to 28 °C. Insulated diabetic footwear and load-bearing activity lead to high plantar tissue temperatures and increased risk of DFU. The purpose of this study was to design/develop a novel temperature regulating footwear and test cooling effectiveness. An extra-depth diabetic shoe was instrumented with temperature control apparatus set to cool to 28 °C. Three subjects wore this shoe and a non-cooling (control) shoe while walking for 10 minutes. Post-walking thermographs of the regulated foot revealed: forefoot temperatures below 28 °C; heel temperatures around 28 °C with a 3.9 °C bilateral cooling effect; midfoot regions 2.9 °C less than the control foot but still over 28 °C, perhaps due to poor contact with the cooling insole or a need for increased localized control of cooling. These results suggest feasibility of in-shoe temperature regulation. Further research is needed to improve our design and ultimately explore DFU prevention in a clinical trial. Disclosure A. Ersen: Other Relationship; Self; Vivonics Inc. L.S. Adams: Other Relationship; Self; Vivonics, Inc. R.T. Myers: Employee; Self; Vivonics, Inc. G.B. Hirschman: Stock/Shareholder; Self; Vivonics, Inc.. Employee; Self; Vivonics, Inc.. Board Member; Self; Vivonics, Inc. L.A. Lavery: Speaker9s Bureau; Self; Osiris Therapeutics, Inc., Integra LifeSciences. Research Support; Self; Cardinal. Speaker9s Bureau; Self; Smith u0026 Nephew. Research Support; Self; EO2. Consultant; Self; Aplion, Harbor MedTech, Boehringer Ingelheim GmbH, Medline Industries, Inc. M. Yavuz: Research Support; Self; Derma Sciences, PulseFlow Technologies. Other Relationship; Self; vivonics.