Diabetes affects around 537 million worldwide, with 19% to 34% developing foot ulcers. Neuropathy is a major risk factor for foot ulceration and one of the causes for a foot ulcer is abnormal biomechanical loading of the foot due to changes in foot structure. This mechanical stress may go unnoticed due to loss of protective sensation and lead to skin breakdown and ulceration. Foot ulcers can lead to amputation and death. Pressure-relieving footwear, such as custom-made rocker shoes and insoles, are used to reduce pressure and prevent ulceration. However, effectiveness of current therapeutic footwear relies on the expertise of pedorthists and manual production, which lacks precision and reproducibility and thereby effectiveness. Additionally, potential changes in foot structure can make the footwear less effective over time. Current pressure-relieving footwear can also negatively impact dynamic stability, which is a concern for individuals with diabetes who may already experience stability issues.
To address these challenges, during this thesis Athra Malki developed an algorithm-based individualized rocker midsole and a self-adjusting insole. Both the midsole and insole are 3D-printed, eliminating the need for manual production and enhancing precision. The insole is made with hexagonal structure that adapts to changes in plantar pressure. Both the midsole and insole are also designed to optimize dynamic stability. During development, we incorporated user perspectives and bridged a knowledge gap needed to create the rocker midsole. Our clinical trials showed that our footwear effectively reduces high pressure values in the forefoot without negative effects on heel pressure and dynamic stability.
