3D Printed vs Ready-to-Wear Insoles for Diabetic Neuropathy (3DP-DPN)

June 6, 2026 updated by: Anbreena Rasool, University of Faisalabad

Comparative Effect of 3D Printed Customized Insoles and Ready to Wear Insoles on Plantar Pressure Changes in Patients With 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-blind, parallel-group randomized controlled trial conducted at DHQ-1 and DHQ-2 hospitals in Okara, Pakistan. Participants are adults aged 35-65 years with diagnosed diabetic neuropathy who can walk independently without aids. Exclusion criteria include foot ulcers, external wounds, recent surgery, major limb amputation, foot drop, peripheral vascular disease, neuromuscular diseases, and Charcot arthropathy. A consecutive sampling technique is used to recruit 22 participants. Randomization is performed using a computer-generated sequence. Participants are blinded to their group allocation. Group A receives 3D printed customized insoles tailored to individual foot morphology using 3D scanning and printing technology. These insoles provide arch support and gait alignment. Group B receives ready-to-wear insoles providing general cushioning and basic support. Both groups follow an 8-week intervention protocol: participants wear insoles for a minimum of 6 hours per day, 5 days per week, and perform level walking on a 28-meter pathway at self-selected speed. The protocol is divided into phases: weeks 1-2 for acclimatization and footwear assessment using Semmes-Weinstein 10g monofilament; weeks 3-4 for pressure adaptation and skin monitoring; weeks 5-6 for enhanced foot function and balance improvement; weeks 7-8 for final assessment. Primary outcome: plantar pressure measured via piezoresistive sensors and Arduino Nano Unit. Secondary outcomes: Foot Health Status Questionnaire (FSHQ), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0), Neuropathy Symptom Score (NSS), and Neuropathy Deficit Score (NDS). Data are collected at baseline, week 4, and week 8. Statistical analysis uses SPSS version 22.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 3800
        • The University of Faisalabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: 3D Printed Customized Insoles
Participants in this group receive 3D printed customized insoles tailored to individual foot morphology. Insoles are designed to provide arch support and gait alignment. Participants wear insoles for minimum 6 hours/day, 5 days/week for 8 weeks, following a phased protocol of acclimatization, pressure adaptation, and function improvement.
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.
Active Comparator: Group B: Ready-to-Wear Insoles
Participants in this group receive prefabricated ready-to-wear insoles providing general cushioning and basic support. Participants wear insoles for minimum 6 hours/day, 5 days/week for 8 weeks, following the same phased protocol as the experimental group.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Plantar Pressure Distribution
Time Frame: Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
Plantar pressure is measured using piezoresistive sensors connected to an Arduino Nano Unit. Participants walk barefoot across the sensor platform. The sensor records pressure distribution across the plantar surface in kilopascals (kPa). Higher pressure values indicate greater plantar load, which is associated with increased risk of foot ulceration. Lower pressure values indicate better offloading.
Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot Health Status Questionnaire (FSHQ) Score
Time Frame: Baseline (Week 0), Week 4, Week 8
The Foot Health Status Questionnaire (FSHQ) is a validated instrument assessing foot-related quality of life. It includes domains of foot pain, foot function, footwear, and general foot health. Each item is scored on a Likert scale. Higher scores indicate better foot health status.
Baseline (Week 0), Week 4, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Faisalabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

June 6, 2026

First Submitted That Met QC Criteria

June 6, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUF/EIRB/ 195 /26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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