Pes PlanusInsolesNCT07022093
Effects of Custom-Designed 3D-Printed and CAD-CAM Insoles on Individuals With Flexible Flatfoot
A study testing Custom made insoles in people with Pes Planus, run by GÖZDE KESİKBAŞ at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- Custom made insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2024to 9 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pes Planus
- Being tested
- Custom made insoles
- Keywords
- pes planus, 3D insoles, custom made insoles
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom made insolesDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Custom insoles manufactured using CNC technology | Active comparator | Customised insoles will be produced using CNC technology and delivered based on the analyses of 20 patients with pes planus. Receives: Device: Custom made insoles |
| Custom insoles produced using 3D technology | Active comparator | Custom insoles produced using 3D technology will be delivered to 20 patients with pes planus. Receives: Device: Custom made insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Foot Function Index (FFI) Score
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.
Measured: Baseline and 8 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start9 Oct 2024
- Primary completion9 Oct 2025
- Study completion9 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pes PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are allocated to two parallel groups for intervention and control, evaluated over the same study duration.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- GÖZDE KESİKBAŞ
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, GÖZDE KESİKBAŞ, Lokman Hekim University
- Investigators
- Nilgün Bek, PhD, Study director, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022093
- Sponsor's protocol ID
- 2024211
- Acronym
- Insoles
- Status last verified
- Jan 2026
- First submitted
- 31 May 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Daryabor A, Kobayashi T, Saeedi H, Lyons SM, Maeda N, Naimi SS. Effect of 3D printed insoles for people with flatfeet: A systematic review. Assist Technol. 2023 Mar 4;35(2):169-179. doi: 10.1080/10400435.2022.2105438. Epub 2022 Aug 24.
PubMed 35882078Yarwindran, M., Sa'aban, N. A., Ibrahim, M., & Periyasamy, R. (2016). Thermoplastic elastomer infill pattern impact on mechanical properties 3D printed customized orthotic insole. ARPN J. Eng. Appl. Sci, 11(7).
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Custom-Designed 3D-Printed and CAD-CAM-Produced Insoles in Individuals With Flexible Pes Planus
- ClinicalTrials.gov ID
- NCT07022093
- Acronym / sponsor ID
- Insoles / 2024211
- Conditions
- Pes Planus
- Keywords
- pes planus, 3D insoles, custom made insoles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GÖZDE KESİKBAŞOther government
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are allocated to two parallel groups for intervention and control, evaluated over the same study duration.
| Arm | Type | Receives |
|---|---|---|
| Custom insoles manufactured using CNC technology | Active comparator | Device: Custom made insolesCustomised insoles will be produced using CNC technology and delivered based on the analyses of 20 patients with pes planus. |
| Custom insoles produced using 3D technology | Active comparator | Device: Custom made insolesCustom insoles produced using 3D technology will be delivered to 20 patients with pes planus. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom made insolesAlso: InsolesFor 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. | Device | Custom insoles manufactured using CNC technology, Custom insoles produced using 3D technology |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Background: PubMed 35882078Daryabor A, Kobayashi T, Saeedi H, Lyons SM, Maeda N, Naimi SS. Effect of 3D printed insoles for people with flatfeet: A systematic review. Assist Technol. 2023 Mar 4;35(2):169-179. doi: 10.1080/10400435.2022.2105438. Epub 2022 Aug 24.
- BackgroundYarwindran, M., Sa'aban, N. A., Ibrahim, M., & Periyasamy, R. (2016). Thermoplastic elastomer infill pattern impact on mechanical properties 3D printed customized orthotic insole. ARPN J. Eng. Appl. Sci, 11(7).
- Individual participant dataSharing planned: Undecided
Related trials for Pes Planus
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The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
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Not yet recruitingObservational study
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilgün Bek, PhD study director
Lokman Hekim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom made insoles in people with Pes Planus, run by GÖZDE KESİKBAŞ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Foot Function Index (FFI) Score (time frame: Baseline and 8 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07022093, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.