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

NCT07641764 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-06-17

No results posted yet for this study

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.

Conditions

  • Diabetic Foot
  • Diabetic Neuropathies

Interventions

DEVICE

3D Printed Customized Insole

3D printed customized insoles are fabricated using 3D scanning of the participant's foot to capture individual morphology. The insoles are printed using thermoplastic polyurethane (TPU) or similar 3D printing filament. The intervention involves daily wear of insoles for minimum 6 hours per day, 5 days per week, for 8 weeks. Participants perform level walking on a 28-meter pathway at self-selected speed. Weekly assessments monitor adherence, skin condition, and comfort. Patient education on foot care and insole use is provided.

DEVICE

Ready-to-Wear Insole

Ready-to-wear insoles are prefabricated insoles providing general cushioning and shock absorption. These insoles are not customized to individual foot morphology. The intervention involves daily wear of insoles for minimum 6 hours per day, 5 days per week, for 8 weeks. Participants perform level walking on a 28-meter pathway at self-selected speed. Weekly assessments monitor adherence, skin condition, and comfort. Patient education on foot care and insole use is provided.

Sponsors & Collaborators

  • University of Faisalabad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-06-30
Completion
2026-07-15

Countries

  • Pakistan

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07641764 on ClinicalTrials.gov