A Method for Diabetic Wound Specific Insole Design, Manufacturing and Biomechanical Validation for Better Recovery.

Abstract

Muscle disorders may cause a change in plantar pressures by the misalignment on the foot during gait phases. Therefore, corns or calluses develop at the plantar regions, and diabetic foot ulcers follow for severe cases although it can be prevented and even treated by podiatric approaches with patient specific therapeutic insole and footwear. Although the importance of a threshold value of 200 kPa in peek plantar pressure reduction has been highlighted as a gold standard to prevent re-ulceration in diabetic foot, it may not be possible to ensure this pressure reduction for each patient. In this study, 3 types of ethylene-vinyl acetate have been utilized to optimize the off-loading performance for pre-determined early-stage diabetic foot ulcer scenarios by means of baropodometric plantar pressure analyses and finite element method for each gait phase. The total cost of the manufacturing for this study was reduced down to $10.26 and was performed in 24.6 minutes. In addition, the offloaded pressure was increased by 2.3 times while the volume of the off-loading geometry was increased 8.12 times based on the utilized foam polymer. Consequently, improved off-loading was obtained and a standard was proposed for the first time to calculate the off-loading performance before manufacturing of the therapeutic insole model to ensure a better recovery period.