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

January 13, 2026 updated by: GÖZDE KESİKBAŞ

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

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

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

Accepts Healthy Volunteers

No

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Custom insoles manufactured using CNC technology
Customised insoles will be produced using CNC technology and delivered based on the analyses of 20 patients with pes planus.
Device: Custom made insoles
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
Active Comparator: Custom insoles produced using 3D technology
Custom insoles produced using 3D technology will be delivered to 20 patients with pes planus.
Device: Custom made insoles
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 8 weeks after intervention

Collaborators and Investigators

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

Sponsor

GÖZDE KESİKBAŞ

Investigators

  • Study Director: Nilgün Bek, PhD, Lokman Hekim University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 9, 2024

Primary Completion (Actual)

October 9, 2025

Study Completion (Actual)

October 9, 2025

Study Registration Dates

First Submitted

May 31, 2025

First Submitted That Met QC Criteria

June 11, 2025

First Posted (Actual)

June 15, 2025

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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