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

N/AActive Not RecruitingNCT07641764

University of Faisalabad22 enrolled

Overview

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.

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

Interventions

3D Printed Customized InsoleDEVICE

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.

Ready-to-Wear InsoleDEVICE

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.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)

Secondary Outcomes

Foot Health Status Questionnaire (FSHQ) Score

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.

Time frame: Baseline (Week 0), Week 4, Week 8