3D Printed vs Ready-to-Wear Insoles for Diabetic Neuropathy

Diabetic neuropathy is a condition caused by chronic high blood glucose levels that damage nerves over time, frequently causing abnormal plantar pressure and increasing the risk of foot ulcers and impaired mobility. Insoles are widely used to redistribute pressure and improve comfort. This study compares the effect of 3D printed customized insoles versus ready-to-wear insoles on plantar pressure changes in patients with diabetic neuropathy. The study is a randomized controlled trial with 22 participants randomly allocated to two groups: one receiving 3D printed customized insoles and the other receiving ready-to-wear insoles. Plantar pressure is measured using piezoresistive sensors and an Arduino Nano Unit. Secondary outcomes include foot health status (FSHQ questionnaire), satisfaction with assistive technology (QUEST 2.0), and neuropathy severity (NSS and NDS questionnaires). Assessments occur at baseline, 4 weeks, and 8 weeks.

Inclusion Criteria: * Age 35 to 65 years * Diagnosed with diabetes mellitus * Clinical diagnosis of diabetic peripheral neuropathy * Ability to walk independently without walking aids * Normal cognitive function * Corrected or uncorrected vision sufficient for safe ambulation * Willingness to provide written informed consent Exclusion Criteria: * Presence of active foot ulcer * External wound on lower extremity * History of lower limb surgery within past 6 months * Major lower limb amputation * Foot drop * Peripheral vascular disease * Neuromuscular diseases (e.g., stroke, Parkinson's disease, multiple sclerosis) * Charcot arthropathy * Inability to comply with study protocol