Foot DeformitiesNCT07136649
Custom CAD/CAM Insoles for Plantar Pressure Improvement in Foot Deformities
A study testing Custom CAD/CAM Insoles in people with Foot Deformities and Orthotic Device, run by Fenerbahce University.
Trial summary
This randomized controlled trial will investigate the effects of custom CAD/CAM insoles on plantar pressure distribution and gait parameters in individuals with foot deformities, such as pes planus, pes cavus, and hallux valgus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Foot Deformities, Orthotic Device, 3D Printing
- What is being tested?
- Custom CAD/CAM Insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- Clinically diagnosed with a foot deformity (e.g., pes planus, pes cavus, hallux valgus)
- Able to use custom insoles for at least six months
- Able to stand and walk for pedobarographic measurements
- Willing to participate and provide informed consent
Who cannot join
- Presence of neurological or systemic diseases affecting foot function (e.g., diabetic neuropathy)
- History of lower extremity surgery in the last six months
- Severe musculoskeletal conditions impairing sensorimotor function
- Any condition preventing compliance with insole use
- Contraindications for participating in gait or pressure measurements
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Custom CAD/CAM Insoles on Plantar Pressure Distribution in Individuals With Foot Deformities: A Randomized Controlled Trial
This randomized controlled trial will investigate the effects of custom CAD/CAM insoles on plantar pressure distribution and gait parameters in individuals with foot deformities, such as pes planus, pes cavus, and hallux valgus. A total of 30 participants will be randomly assigned to either the intervention group, receiving custom CAD/CAM insoles, or the control group, receiving no insole intervention.
Plantar pressure measurements will be performed using the As200 Gait Scan Pedobarography System at baseline and after eight weeks. Static and dynamic plantar pressure variables, contact area, and center of pressure displacement will be assessed, along with gait parameters including step length, step time, and walking speed.
The results of this study may contribute to the development of effective conservative treatment strategies to improve foot biomechanics and reduce pressure-related complications in individuals with foot deformities.
Read the detailed description
This randomized controlled trial will evaluate the impact of custom CAD/CAM insoles on plantar pressure distribution and gait parameters in individuals with clinically diagnosed foot deformities. Thirty eligible participants, aged 18-65 years, will be randomly assigned to one of two groups:
Intervention Group: Participants will receive custom-designed CAD/CAM insoles based on 3D plantar scans and pedobarographic analysis.
Control Group: Participants will not receive insole intervention during the eight-week study period.
Baseline assessments will include demographic data, anthropometric foot measurements, and pedobarographic analysis using the As200 Gait Scan System. The intervention group will be instructed to use the custom insoles daily for eight consecutive weeks, while the control group will maintain their usual footwear without insoles.
After eight weeks, all participants will undergo the same measurement procedures. Primary outcome measures will include maximum and mean plantar pressures, contact area, and center of pressure displacement. Secondary outcomes will include step length, step time, walking speed, and regional pressure distribution across foot segments.
Data analysis will be conducted using repeated-measures statistical models to evaluate time × group effects, with significance set at p < 0.05. The study will be conducted at the Kale Prosthetics and Orthotics Center between September and November 2025, following approval from the Fenerbahçe University Non-Interventional Clinical Research Ethics Committee.
- Conditions
- Foot Deformities, Orthotic Device, 3D Printing, CAD
- Being tested
- Custom CAD/CAM Insoles
- Keywords
- Custom CAD/CAM Insoles, Pes Planus, Pes Planovalgus, Pes Cavus, Pedobarography, Plantar Pressure, 3D Printing, Orthotics
- Medical subject headings
- Foot Deformities, Flatfoot, Clubfoot, Talipes Cavus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom CAD/CAM InsolesDevice
Custom insoles will be designed using 3D plantar scanning and pedobarographic analysis, produced with CAD/CAM technology. The insoles will be fitted into participants' regular footwear and worn daily for eight consecutive weeks. The design aims to optimize plantar pressure distribution and improve foot biomechanics in individuals with foot deformities.
| Study group | Role | What they receive |
|---|---|---|
| Custom CAD/CAM Insole Group | Experimental | Participants in this group will receive custom CAD/CAM insoles designed based on 3D plantar scans and pedobarographic analysis. The insoles will be fitted into their regular footwear and used daily for eight consecutive weeks. Receives: Device: Custom CAD/CAM Insoles |
| Control Group (No Insole Intervention) | No intervention | Participants in this group will not receive any insole intervention during the eight-week study period and will continue using their usual footwear. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plantar Pressure
Maximum plantar pressure (kPa) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Measured: Baseline and 8 weeks after intervention.
Mean Plantar Pressure
Mean plantar pressure (kPa) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Measured: Baseline and 8 weeks after intervention.
Plantar Contact Area
Plantar contact area (cm²) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Measured: Baseline and 8 weeks after intervention.
Center of Pressure (COP) Displacement
Center of pressure (COP) displacement (mm) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Measured: Baseline and 8 weeks after intervention.
Secondary outcomes (4)
Step Length
Step length (cm) assessed using the As200 Gait Scan Pedobarography System under dynamic walking conditions.
Measured: Baseline and 8 weeks after intervention
Step Time
Step time (ms) assessed using the As200 Gait Scan Pedobarography System under dynamic walking conditions.
Measured: Baseline and 8 weeks after intervention
Walking Speed
Walking speed (m/s) assessed using the As200 Gait Scan Pedobarography System under dynamic walking conditions.
Measured: Baseline and 8 weeks after intervention.
Regional Pressure Distribution
Plantar pressure distribution by foot regions (kPa) assessed using the As200 Gait Scan Pedobarography System.
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 posted22 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot DeformitiesStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- 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 will be randomly assigned to either the intervention group, receiving custom CAD/CAM insoles, or the control group, receiving no insole intervention, with both groups assessed at baseline and after eight weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başar Öztürk, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136649
- Sponsor's protocol ID
- assoc.prof.basarozturk
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Custom CAD/CAM Insoles on Plantar Pressure Distribution in Individuals With Foot Deformities: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07136649
- Acronym / sponsor ID
- assoc.prof.basarozturk
- Conditions
- Foot Deformities, Orthotic Device, 3D Printing, CAD
- Keywords
- Custom CAD/CAM Insoles, Pes Planus, Pes Planovalgus, Pes Cavus, Pedobarography, Plantar Pressure, 3D Printing, Orthotics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 22 Aug 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 randomized controlled trial will investigate the effects of custom CAD/CAM insoles on plantar pressure distribution and gait parameters in individuals with foot deformities, such as pes planus, pes cavus, and hallux valgus. A total of 30 participants will be randomly assigned to either the intervention group, receiving custom CAD/CAM insoles, or the control group, receiving no insole intervention.
Plantar pressure measurements will be performed using the As200 Gait Scan Pedobarography System at baseline and after eight weeks. Static and dynamic plantar pressure variables, contact area, and center of pressure displacement will be assessed, along with gait parameters including step length, step time, and walking speed.
The results of this study may contribute to the development of effective conservative treatment strategies to improve foot biomechanics and reduce pressure-related complications in individuals with foot deformities.
Detailed description
This randomized controlled trial will evaluate the impact of custom CAD/CAM insoles on plantar pressure distribution and gait parameters in individuals with clinically diagnosed foot deformities. Thirty eligible participants, aged 18-65 years, will be randomly assigned to one of two groups:
Intervention Group: Participants will receive custom-designed CAD/CAM insoles based on 3D plantar scans and pedobarographic analysis.
Control Group: Participants will not receive insole intervention during the eight-week study period.
Baseline assessments will include demographic data, anthropometric foot measurements, and pedobarographic analysis using the As200 Gait Scan System. The intervention group will be instructed to use the custom insoles daily for eight consecutive weeks, while the control group will maintain their usual footwear without insoles.
After eight weeks, all participants will undergo the same measurement procedures. Primary outcome measures will include maximum and mean plantar pressures, contact area, and center of pressure displacement. Secondary outcomes will include step length, step time, walking speed, and regional pressure distribution across foot segments.
Data analysis will be conducted using repeated-measures statistical models to evaluate time × group effects, with significance set at p < 0.05. The study will be conducted at the Kale Prosthetics and Orthotics Center between September and November 2025, following approval from the Fenerbahçe University Non-Interventional Clinical Research Ethics Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the intervention group, receiving custom CAD/CAM insoles, or the control group, receiving no insole intervention, with both groups assessed at baseline and after eight weeks.
| Arm | Type | Receives |
|---|---|---|
| Custom CAD/CAM Insole Group | Experimental | Device: Custom CAD/CAM InsolesParticipants in this group will receive custom CAD/CAM insoles designed based on 3D plantar scans and pedobarographic analysis. The insoles will be fitted into their regular footwear and used daily for eight consecutive weeks. |
| Control Group (No Insole Intervention) | No intervention | –Participants in this group will not receive any insole intervention during the eight-week study period and will continue using their usual footwear. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years
- Clinically diagnosed with a foot deformity (e.g., pes planus, pes cavus, hallux valgus)
- Able to use custom insoles for at least six months
- Able to stand and walk for pedobarographic measurements
- Willing to participate and provide informed consent
Key exclusion criteria (5 listed)
- Presence of neurological or systemic diseases affecting foot function (e.g., diabetic neuropathy)
- History of lower extremity surgery in the last six months
- Severe musculoskeletal conditions impairing sensorimotor function
- Any condition preventing compliance with insole use
- Contraindications for participating in gait or pressure measurements
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 CAD/CAM InsolesCustom insoles will be designed using 3D plantar scanning and pedobarographic analysis, produced with CAD/CAM technology. The insoles will be fitted into participants' regular footwear and worn daily for eight consecutive weeks. The design aims to optimize plantar pressure distribution and improve foot biomechanics in individuals with foot deformities. | Device | Custom CAD/CAM Insole Group |
Primary outcome
Maximum Plantar Pressure
Time frame: Baseline and 8 weeks after intervention.
Maximum plantar pressure (kPa) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Mean Plantar Pressure
Time frame: Baseline and 8 weeks after intervention.
Mean plantar pressure (kPa) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Plantar Contact Area
Time frame: Baseline and 8 weeks after intervention.
Plantar contact area (cm²) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Center of Pressure (COP) Displacement
Time frame: Baseline and 8 weeks after intervention.
Center of pressure (COP) displacement (mm) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
4 secondary outcomes
Step Length
Time frame: Baseline and 8 weeks after intervention
Step Time
Time frame: Baseline and 8 weeks after intervention
Walking Speed
Time frame: Baseline and 8 weeks after intervention.
Regional Pressure Distribution
Time frame: Baseline and 8 weeks after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Recruiting
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RecruitingObservational study
A Study of VIRTUGUIDE System and DePuy Synthes Lapidus Implant in Participants Undergoing Lapidus Procedure
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Not yet recruitingObservational study
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Custom CAD/CAM Insoles in people with Foot Deformities and Orthotic Device, run by Fenerbahce University.
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: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BAŞAR ÖZTÜRK, Assoc. Prof. (+905370150630, basar.ozturk@fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plantar Pressure (time frame: Baseline and 8 weeks after intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2025.