Development of Cyclic Pressure Offloading Insole for Diabetic Foot Ulcer Prevention.

Introduction. The likelihood of developing a diabetic foot ulcer (DFU) during one's lifetime for individuals with diabetes mellitus is around 19% to 34%. Continuous and repetitive loading on soft tissues are the major causative factors for DFU. This paper introduces an air cell array insole designed for cyclically offloading pressure from plantar regions to reduce repetitive stress and loading on foot. Materials and Methods. The insole comprises an air cell array insole and a pneumatic control unit. The interface pressure was evaluated in static and dynamic conditions at 3 different air cell internal pressures (6.9, 10.3, and 13.8 kPa). Plantar interface pressure was measured using a commercial pressure system, and data were analyzed using paired t test. Average interface pressure and peak pressure (PP) were studied to evaluate the functionality and effectiveness of the insole. Results. The analysis of static pressure data revealed that cyclic offloading significantly ( p  < .05) reduced PP in 4 tested cells corresponding to big toe, metatarsal heads, and heel areas with the maximum mean difference of 12.9 kPa observed in big toe region. Similarly, dynamic pressure data analysis showed that cyclic offloading significantly ( p  < .05) reduced PP in these areas, with the highest mean PP reduction of 36.98 kPa in the big toe region. Discussion. Results show the insole's capability to reduce plantar pressure through cyclic offloading. Internal pressure of air cells significantly affects the overall pressure reduction and must be chosen based on the user's weight. Conclusion. Results confirm that the insole with offloading capabilities has the potential to reduce the risk of developing DFUs by alleviating the plantar stress during both static and dynamic conditions.