Can custom foot orthoses outperform standard ones for painful flatfoot?
NCT ID NCT07756372
First seen Aug 10, 2026 · Last updated Aug 20, 2026 · Updated 3 times
Summary
This trial tests whether adding custom-made, prefabricated, or sham (fake) foot orthoses to a standard exercise and education program can reduce foot pain and improve function in adults with progressive collapsing foot deformity, a condition that causes a painful, flattening foot. About 198 participants will be randomly assigned to one of three groups and followed for a year. The study aims to see if orthoses help at all, and if so, which type works best.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Customized 3D-printed foot orthoses, prefabricated foot orthoses, or sham foot orthoses, combined with a home exercise program and education
- What this could lead to
- If effective, this could guide doctors in prescribing the best type of foot orthosis to reduce pain and improve mobility in people with progressive collapsing foot deformity.
- What could go wrong
- This is a relatively small trial, and results may not apply to everyone. The sham orthoses help control for placebo effects, but the true benefit of custom versus prefabricated orthoses remains uncertain.
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
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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
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About 198 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Present with PCFD according to Myerson et al. (M. S. Myerson et al., 2020) classification * Report medial ankle or foot pain lasting six weeks or more with a pain score of ≥ 3 out of 10 on a Visual Analogue Scale (VAS) and pain to the posterior tibial tendon * Are aged 18 to 70 years, * Can walk without assistive devices (e.g., cane, walker), * Are willing to wear shoes that accommodate their FOs daily, * Are willing to minimize the use of other interventions (e.g., pain medications, physical therapy) during the trial period. * Obtain a positive result on the single and/or double heel rise test (important pain during the test or inability to perform the test). Exclusion Criteria: * Are classified as having Stage II rigid deformities according to Myerson classification, * Have a history of musculoskeletal surgery to the foot and ankle, * Present cognitive impairment, * Are currently pregnant or breastfeeding, * Have worn FOs within the past year.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris)
Québec, Quebec, G1M 2S8, Canada
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Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G9A 5H7, Canada