Custom CAD/CAM Insoles for Plantar Pressure Improvement in Foot Deformities

Fenerbahce University

Status: Not yet enrolling

Conditions: 3D Printing; CAD; Foot Deformities; Orthotic Device

Treatments: Device: Custom CAD/CAM Insoles

Study type: Interventional

Funder types: Other

Identifiers

NCT07136649

assoc.prof.basarozturk

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Custom CAD/CAM Insole Group

Experimental group

Description:

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.

Treatment:

Device: Custom CAD/CAM Insoles

Control Group (No Insole Intervention)

No Intervention group

Description:

Participants in this group will not receive any insole intervention during the eight-week study period and will continue using their usual footwear.