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

ABSTRACT

BACKGROUND: 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 insoles and footwear. Although the importance of a threshold value of 200 kPa in peak plantar pressure reduction has been highlighted as a standard to prevent reulceration in the diabetic foot, it may not be possible to ensure this pressure reduction for each patient. METHODS: In this study, three types of ethylene-vinyl acetate have been used to optimize the off-loading performance for predetermined early-stage diabetic foot ulcer scenarios by means of baropodometric plantar pressure analyses and finite element method for each gait phase. RESULTS: The total cost of the manufacturing for this study was reduced to $10.26 and it was performed in 24.6 minutes. In addition, the off-loaded pressure was increased by 2.3 times and the volume of the off-loading geometry was increased 8.12 times based on the foam polymer used. CONCLUSIONS: 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.