Clinical Trial

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

Study acronym: 3DP-DPN
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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.
Trial Details
NCT Number NCT07641764
Lead Sponsor University of Faisalabad
Conditions Diabetic Foot, Diabetic Neuropathies
Enrollment 22 participants
Start Date 2026-01-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-07-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-11