Improving the prevention of foot ulcers in diabetes Integrating footwear biomechanics and patient behavior in a multimodal intervention

Diabetes-related foot ulcers are a common complication for people with diabetes, with a lifetime risk of up to 34%. Risks are increasing after the first ulcer occurred, as 40% develops a recurrent ulcer within one year after healing, leading to a high patient and healthcare burden. Therefore, prevention of foot ulcers is key. Recommendations for interventions to reduce these risks are biomechanical, such as providing pressure-optimized footwear, or behavioral, such as encouraging footwear use and promoting self-care. Preferably, these interventions are combined in an integrated approach. This led to the development of the DIASSIST trial, a multicenter randomized controlled trial including 126 participants which aimed to assess the effectiveness of such an integrated personalized multimodal approach. In this thesis, the trial protocol and the results of the trial are presented. As the approach is multimodal, this thesis is divided into three parts. Part 1 is focused on footwear biomechanics, where the aim was to improve pressure distribution of regular and indoor-specific custom-made footwear by using plantar pressure measurements and scientific evidence on footwear design. Part 2 is focused on patient behavior, with the aim of improving adherence to wearing the pressure-optimized custom-made footwear by providing indoor custom-made footwear, structured education and motivational interviewing. Part 3 is focused on the clinical effectiveness of the intervention. This part combines the optimized biomechanical and behavioral aspects of the integrated personalized multimodal approach to investigate its effectiveness on foot ulcer recurrence in people with diabetes at high risk of foot ulceration.