RESUMEN
BACKGROUND: Effectiveness of therapeutic footwear in reducing peak pressure in persons with diabetes and loss of protective sensation to prevent diabetic foot ulcers varies due to manual production and possible changing foot structure. A previous two-way approach to address this issue, featuring individualized 3D-printed rocker midsoles and self-adjusting insoles, proved effective in the forefoot but less in the heel. To address this, new insoles incorporating a heel cup are developed. METHODS: In-shoe pressure was measured, while persons with diabetes and loss of protective sensation with high peak pressure (≥ 200 kPa) in the heel walked on a treadmill with control and individualized rocker shoe paired with control and new insole. FINDINGS: Generalized estimating equations revealed significant decrease in peak pressure in the proximal heel with the new insole alone and combined with rocker shoe compared to rocker shoe alone. For the distal heel, significant decrease in peak pressure is shown with the combination of new insole and rocker shoe compared to control shoe. For the forefoot and toes (excluding hallux) significant decrease in peak pressure is shown using the rocker shoe alone or combined with the heel cup compared to control shoe. INTERPRETATION: The new insole paired with rocker shoe is effective in reducing peak pressure in the distal heel. To have similar (or more) success in proximal heel, one could replace the rocker midsole with more compliant materials. The rocker shoe used separately or combined with a heel cup effectively reduces the peak pressure in the forefoot and other toes.