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Orthotic Impact on MTP Alignment in Hallux Valgus

NCT07378917 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-04-28

No results posted yet for this study

Summary

This study aims to evaluate the effectiveness of an external corrector in realigning the first metatarsophalangeal joint in patients with mild to moderate Hallux Abducto Valgus, according to the Manchester scale. Changes in valgus angle will be assessed through radiographs, along with pain, comfort and adherence, comparing results with a control group.

Conditions

  • Hallux Valgus

Interventions

DEVICE

Hallux Valgus Orthosis

This study evaluates the effectiveness of an external hallux valgus orthosis in realigning the first metatarsophalangeal joint in patients with mild to moderate HAV. Two radiographic measurements of the valgus angle will be taken: at baseline and after 3 months of daily orthosis use. Participants will receive instructions for proper placement and adjustment. Secondary outcomes include pain (VAS), comfort, satisfaction, plantar pressure analysis (static/dynamic), device fit, and adherence. Data will be collected by podiatrists and anonymized for analysis.

Sponsors & Collaborators

  • University of Valencia

    lead OTHER

Principal Investigators

  • CARMEN GARCÍA GOMARIZ · UNIVERSITAT DE VALÉNCIA DEPARTAMENTO D'INFERMERIA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-22
Primary Completion
2026-03-30
Completion
2026-04-27

Countries

  • Spain

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 NCT07378917 on ClinicalTrials.gov