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Could a simple toe brace fix bunions without surgery?

NCT ID NCT07378917

Disease control Sponsor: University of Valencia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether wearing an external toe brace for 3 months can improve joint alignment in people with mild to moderate bunions (hallux valgus). Thirty-five adults used the brace daily, and researchers measured changes in the bunion angle on X-rays, along with pain, comfort, and satisfaction. The goal is to see if a non-surgical device can help realign the toe and ease symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hallux valgus orthosis (external toe brace)
What this could lead to
If it works, this could offer a non-surgical way to improve toe alignment and reduce pain for people with mild to moderate bunions.
What could go wrong
This is a small, completed study with only 35 participants. The orthosis may not correct the deformity significantly, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

35 people

The number who actually took part.

Started

Nov 2025

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Sex: Male or female Age: 18 to 80 years Cooperative subject, informed of the need and duration of follow-up visits, ensuring full compliance with the protocol/study, and having signed informed consent No previous surgery on the foot and/or ankle Mild and/or moderate Hallux Valgus (Manchester Scale) Exclusion Criteria: * Patient with severe arteriopathy Patient with severe edema Patient with sensory neuropathy Patients who have used additional pharmacological treatments (analgesics/anti-inflammatories) during the entire study period Severe Hallux Valgus (Manchester Scale) Any systemic disease affecting the musculoskeletal system Rheumatoid arthritis involving the first metatarsophalangeal joint Instability of the first metatarsophalangeal joint History of previous foot and/or ankle surgery Hyperpronated foot with FPI \>10 Severe pathological genu varum or valgum Pregnant women or suspected pregnancy

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Conditions

The condition(s) this trial relates to.

Hallux Valgus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hallux valgus

Contacts and locations

Locations

  • Carmen García Gomariz

    Valencia, 46010, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.