Determining the foot structure and characteristics of diabetic patients for the design and production of custom insoles: Developing a foot defining parameter

Diabetes mellitus is associated with progressive biomechanical changes in foot structure and plantar pressure distribution, leading to an increased risk of ulceration and related complications. The correct design of custom insoles is crucial for effective plantar pressure management. However, integrating additional standardized and data-driven criteria into the prescribing process can further support clinical decision-making. The primary aim of this study was to determine the foot structure and plantar pressure characteristics of individuals with diabetes and to develop individualized insole definition parameters to guide the design and production of custom insoles. A total of 50 diabetic patients (26 women and 24 men) participated in the study. Static plantar pressure measurements and foot anthropometric assessments were performed for each participant. Pressure distribution patterns were analyzed regionally (forefoot, midfoot, hindfoot) and evaluated in relation to biomechanical reference values. Based on these analyses, a set of objective insole definition parameters was determined to meet patient-specific biomechanical needs. Furthermore, a custom software program was developed to automatically process patient input data and generate the corresponding insole parameters. The results demonstrated that plantar pressure data can be systematically converted into structured insole design parameters. The developed software enabled consistent interpretation of biomechanical measurements and supported a more standardized and reproducible process. This integrated clinical-technological approach will contribute to increasing accuracy and efficiency in custom insole design for individuals with diabetes and reducing subjectivity in the clinical decision-making process.