An interventional study of Custom CAD/CAM Insoles in Foot Deformities, Orthotic Device and 3D Printing, sponsored by Fenerbahce University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Fenerbahce University · Not applicable, Interventional, and Treatment
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.
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.
50 studies on the registry are indexed under Foot Deformities; 13 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 26 interventional studies indexed under Foot Deformities.
Browse Foot Deformities studies →Fenerbahce University is the lead sponsor of 74 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Custom CAD/CAM Insoles
Participants in this group will not receive any insole intervention during the eight-week study period and will continue using their usual footwear.
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.
Maximum Plantar Pressure
Maximum plantar pressure (kPa) measured under static and dynamic conditions using the As200 Gait Scan Pedobarography System.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 8 weeks after intervention.
Step Length
Step length (cm) assessed using the As200 Gait Scan Pedobarography System under dynamic walking conditions.
Time frame: Baseline and 8 weeks after intervention
Step Time
Step time (ms) assessed using the As200 Gait Scan Pedobarography System under dynamic walking conditions.
Time frame: Baseline and 8 weeks after intervention
Walking Speed
Walking speed (m/s) assessed using the As200 Gait Scan Pedobarography System under dynamic walking conditions.
Time frame: Baseline and 8 weeks after intervention.
Regional Pressure Distribution
Plantar pressure distribution by foot regions (kPa) assessed using the As200 Gait Scan Pedobarography System.
Time frame: Baseline and 8 weeks after intervention.
Arch Height
Arch height (cm) measured using a digital caliper and measuring tape.
Time frame: Baseline and 8 weeks after intervention.
Navicular Drop
Navicular drop (mm) measured using a digital caliper and measuring tape.
Time frame: Baseline and 8 weeks after intervention.
Hallux Valgus Angle
Hallux valgus angle (degrees) measured using a goniometer.
Time frame: Baseline and 8 weeks after intervention.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Nov 2025, 2 months later.
Of 13 interventional studies with no phase under Foot Deformities, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's planned 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Fenerbahce University