IOF Project

Title	IOF: Intelligent Offloading Footwear for Prevention of Lower Extremity Amputations in People with Diabetes
Dates	January 2022 to February 2027
Principal investigator	Zoltan Pataky (UNIGE/HUG)
Other investigators	Sarah Hemler (K-Lab, UNIGE/HUG)
Institutional collaborations	LAI (EPFL), Giglio Orthopédie SA (Geneva, Switzerland)
Funding	Innosuisse Project Funding (2024-2027) & FNS - Bridge - Discovery #40B2-0_181020 (2020-2023)
Keywords	Diabetes mellitus, pressure offloading, foot ulcers, amputations, medical device, human factors, smart insole
Website	IOF Project
Related articles	Frontiers - Intelligent plantar pressure offloading for the prevention of diabetic foot ulcers and amputations

Abstract
The aim of this project is to develop intelligent pressure-offloading footwear for people with diabetes to automatically redistribute high plantar pressures and thus treat and prevent ulcers and amputations. The high prevalence of lower extremity ulceration and amputation in people with diabetes is strongly linked to difficulties in achieving and maintaining a reduction of high plantar pressures. Current interventions for ulcer prevention and treatment focus on pressure offloading using a variety of footwear, insoles, or walking retraining. However, these solutions have critical limiting factors that reduce adherence, limit long-term efficacy, and are resource intensive. To address these gaps, our team is developing Intelligent Pressure Offloading Footwear (currently undergoing prototype testing). The footwear which is being jointly developed by Prof. Pataky (UNIGE) and Prof. Perriard (EPFL) under an SNSF-BRIDGE Discovery grant (2019-2023) features an insole system that will automatically sense plantar pressures across the foot and offload high-pressure areas by altering the insole contour according to the user’s specific pressure needs. The insole contour is changed by using programmable pressure-limiting modules that respond according to the sensed pressures. The footwear is currently undergoing proof-of-concept testing. Initial testing has shown that a pressure reduction of up to 33% can be achieved directly under an area of high plantar pressure, consistent with pressure reduction recommendations. In addition to mechanical testing, a user perceptions study showed positive feedback regarding the perceived acceptance of footwear in people with diabetes, their caregivers, and medical professionals. The next phase of this project will involve randomized clinical trials to validate this medical device and the development of a startup.