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Product Information Analysis and Clinical Verification - Clinical Verification of New Smart Health Medical Shoes/Insoles

NCT07298629 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-23

No results posted yet for this study

Summary

As part of foot orthotics, insoles play a crucial role in adjusting biomechanical malalignments of the foot and regulating foot pressure. They are commonly used as a clinical tool for correcting foot problems. Currently, most customized insole manufacturing processes mainly depend on traditional or subtractive methods, highly dependent on the manual technology of the manufacturer, and the production capacity is constrained by working hours and cannot be manufactured in large quantities. Consequently, people often need to wait for one to two months with poor timeliness. The 3D printing insole fabrication process offers significant advantages in customization with high design flexibility and freedom. Utilizing microstructural zoning designs can better combine different regional characteristic requirements, thus closely addressing individual requirements. The purpose of this project is to validate the medical process after the initial development of the novel intelligent health medical insole and subsequently introduce the new intelligent health medical insole into clinical applications within medical institutions.

The project plans to recruit 30 participants with foot pain. Participants will be required to provide basic information and evaluated their foot condition. the Tiger Scan 3D full-foot scanning equipment will be used to capture the participants' 3D foot models. Insoles will be customized based on the assessment results, incorporating features such as heel cups, arch supports, and medial wedges. Relevant parameters will be uploaded to a RESTful API correction information platform. Then, the clinical recommendations for adjustment parameters will be output to a 3D printer, producing customized insoles with selective laser sintering (SLS) technology. The outcome assessments encompass short-term and long-term evaluations. Short-term assessments include kinematics and dynamic analysis, foot pressure distribution, physical performance, and foot morphology. Long-term assessments include pain levels, activities of daily living, and changes in quality of life.

Conditions

  • Pronated Foot

Interventions

DEVICE

3d printed insole

This study used 3D printer, producing customized insoles with selective laser sintering (SLS) technology.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Taiwan

Study Locations

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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 NCT07298629 on ClinicalTrials.gov