Abstract
BACKGROUND: Offloading footwear is a critical intervention for preventing and treating diabetic foot ulcers (DFUs), as it reduces plantar pressure (PP) and promotes healing. However, decision-making around its prescription remains fragmented, with variability in feature selection, limited personalization, and diverse evaluation approaches. While guidelines, knowledge-based systems, and machine learning (ML) applications have explored elements of decision-making, no clinical decision support system (CDSS) currently exists to provide feature-level prescriptions. METHODS: We conducted a narrative review of 45 studies, including 12 guidelines/protocols, 25 knowledge-based systems, and eight ML applications. Studies published from inception to August 2025 were included. Studies were thematically analyzed by type of knowledge, decision logic, evaluation methods, and associated technologies. RESULTS: Guidelines emphasize PP thresholds (≤200 kPa or ≥25–30% reduction) but lack detailed outputs. Knowledge-based systems apply rule-based and sensor-driven logic, integrating PP monitoring, adherence tracking, and usability testing. ML applications introduce predictive classification, optimization, and generative models, achieving high computational accuracy but with limited explainability and clinical validation. Evaluation practices remain fragmented: biomechanical testing dominates protocols, usability and adherence assessments are common in knowledge-based systems, while ML studies emphasize technical accuracy without linking to long-term clinical outcomes. From this synthesis, we propose a five-component framework for CDSS development that discusses: (1) minimum viable dataset, (2) hybrid decision architecture combining rules, optimization, and explainable ML, (3) structured feature-level outputs, (4) continuous validation and evaluation, and (5) integration into clinical and telehealth workflows. CONCLUSION: The proposed framework presents a pathway to transform fragmented approaches into scalable, patient-centered CDSSs. Prioritizing interoperable datasets, explainable models, and outcome-driven evaluation will be critical for clinical adoption and improved DFU care.