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

NCT07136649 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-22

No results posted yet for this study

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. 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.

Conditions

  • Foot Deformities
  • Orthotic Device
  • 3D Printing
  • CAD

Interventions

DEVICE

Custom CAD/CAM Insoles

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.

Sponsors & Collaborators

  • Fenerbahce University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-11-15
Completion
2025-11-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07136649 on ClinicalTrials.gov