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Can an Off-the-Shelf insole tame stubborn heel pain?

NCT ID NCT06386406

Symptom relief Sponsor: Ente Ospedaliero Cantonale, Bellinzona 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are studying whether a pre-made plantar insole, designed by shoe size and gender, helps adults with plantar fasciitis that has lasted at least six months and resisted other treatments. About 25 people will wear the insole during everyday walking for one year. The team will track changes in pain using a standard 0-to-10 scale and see whether participants regain mobility and return to normal daily activities.

What this could mean

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

Active substance
a pre-confectioned plantar insole designed by shoe size and gender
What this could lead to
If it works, this could offer an off-the-shelf insole option for people with persistent plantar heel pain, without the cost and wait of custom orthotics.
What could go wrong
The trial is small and single-center, so results may not apply broadly. An off-the-shelf insole may not fit or help everyone, and some people may see no pain relief.

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

25 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

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 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: Male and female adults * Age ranging 18 to 70 years * Patients with a history of at least 6 months of plantar fasciitis resistant to other conventional therapies * Willingness and ability to participate in the trial * Informed Consent signed by the subject Exclusion Criteria: * Diabetes mellitus not controlled pharmacologically * Rheumatoid arthritis * Previous foot surgery * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.

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Conditions

The condition(s) this trial relates to.

plantar fasciitis

As listed by the trial registrant

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

Plantar fascitis

Contacts and locations

Locations

  • EOC

    Lugano, 6900, Switzerland

More trials for these conditions

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