Effects of Custom-Designed 3D-Printed and CAD-CAM Insoles on Individuals With Flexible Flatfoot

This study aims to investigate the effects of custom-designed insoles produced using Computer Numerical Control (CNC) and 3D printers on plantar pressure distribution analysis, foot posture, plantar force distribution, foot pain, and satisfaction in patients diagnosed with pes planus.

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Key information

Conditions

Pes Planus Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University

Samsun, 55139, Turkey (Türkiye)

About this study

This randomized controlled trial evaluates the impact of custom-designed insoles, created using Computer Numerical Control (CNC) and 3D printing technologies, on plantar pressure distribution, foot posture, pain, and user satisfaction in individuals with flexible pes planus. The study targets adults aged 18-55, with specific clinical and postural inclusion criteria, and excludes individuals with biomechanical or neurological confounders.

Participants are randomly assigned to one of two intervention groups using a simple randomization method: one receiving CNC-produced insoles and the other 3D-printed insoles. Assessments are conducted before and after 8 weeks of insole use, employing standardized tools such as the Foot Posture Index, subtalar angle measurement, plantar pressure analysis, and satisfaction/function questionnaires. The primary aim is to explore comparative biomechanical and subjective outcomes to inform best practices in orthotic design and application.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals aged between 18 and 55 years
Diagnosed with flexible pes planus (flat feet)
No prior use of custom orthotic insoles within the past 6 months
Able to walk independently without assistive devices
Voluntarily agree to participate and provide informed consent

Exclusion criteria

History of lower limb or foot surgery
Presence of neurological, rheumatologic, or musculoskeletal disorders affecting gait
Presence of severe foot deformities (e.g., rigid pes planus, cavus foot)
Use of medications that affect muscle or joint function
Pregnancy

Treatment and study plan

Custom made insoles

Device

For the production of insoles using the CAD-CAM method; In the production of insoles, medial longitudinal arch support will be added so that the subtalar joints are in a neutral position, and additionally, transverse arch support between 3.5-5 mm, lateral longitudinal arch support between 4-6 mm, and finger-under supports to assist with palmar grip will be designed in three dimensions using the EasyCad modelling interface. Using a Vulcan Computer Numerical Control (CNC) milling machine, the insoles will be machined from Ethylene Vinyl Acetate (EVA) material placed in blocks. After this process, the insoles will be adjusted on the milling machine to fit the patient's shoes.For the production of insoles using the 3D printing method, the Elegoo Neptune 4 Max 3D printer will be used. Using TPU material, medial longitudinal arch support will be added, along with transverse arch support between 3.5-5 mm, lateral longitudinal arch support between 4-6 mm, and finger support to aid palmar grip.

Other names: Insoles

Primary outcomes

Change in Foot Function Index (FFI) Score

Time frame: Baseline and 8 weeks after intervention

This measure assesses changes in foot pain, disability, and activity limitation using the Foot Function Index (FFI). Participants complete the FFI questionnaire before and after the intervention period. The score ranges from 0 to 100, with higher scores indicating worse foot function.

Sponsors and collaborators

Lead sponsor

GÖZDE KESİKBAŞ

Other Gov

Registry information

Official study title

Investigation of the Effects of Custom-Designed 3D-Printed and CAD-CAM-Produced Insoles in Individuals With Flexible Pes Planus

Acronym: Insoles

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jun 15, 2025
Registry last updated: Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed