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

NCT07641764 | Active Not Recruiting

• 1 other identifier: TUF/EIRB/ 195 /26
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

3D printing; customized insoles; plantar pressure; diabetic neuropathy; Pakistan

Outcome Measures

Primary Outcomes (1)

• Change in Plantar Pressure Distribution

  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 Outcomes (1)

• Foot Health Status Questionnaire (FSHQ) Score

  Baseline (Week 0), Week 4, Week 8

Study Arms (2)

Group A: 3D Printed Customized Insoles

EXPERIMENTAL

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; Device: Ready-to-Wear Insole

Group B: Ready-to-Wear Insoles

ACTIVE COMPARATOR

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

Interventions

3D Printed Customized Insole DEVICE

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.

Group A: 3D Printed Customized Insoles

Ready-to-Wear Insole DEVICE

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.

Group A: 3D Printed Customized Insoles; Group B: Ready-to-Wear Insoles

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

The University of Faisalabad

Faisalābad, Punjab Province, 3800, Pakistan

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Rehabilitation Sciences

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 11, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)