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Can a tiny heel lift in a brace ease foot pain? new study aims to find out.

NCT ID NCT06127316

Symptom relief Sponsor: University of Iowa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how changing the heel distraction height (the gap between the heel and the footplate) in a carbon fiber custom dynamic orthosis (CDO) affects foot loading, pain, and comfort during walking. Twenty adults with traumatic hindfoot injuries will walk with and without the brace at three different heel heights. Researchers will measure forces under the foot and ask about pain and comfort to find the best setup.

What this could mean

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

Active substance
Carbon fiber custom dynamic orthosis (CDO) with adjustable heel distraction height
What this could lead to
If successful, this could help design better orthoses that reduce pain and improve comfort during walking for people with foot injuries.
What could go wrong
This is a small, early-stage study with only 20 participants, so results may not apply to everyone. It focuses on short-term walking tests, not long-term outcomes.

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Jun 2026

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 65 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: 1. Ages 18-65 years 2. Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot or ankle) 3. Mechanical pain with limb loading (\>=4/10 on Numerical Pain Rating Scale) 4. Ability to walk 50 feet at a slow to moderate pace 5. Ability to walk without a cane or crutch 6. Ability to read and write in English and provide written informed consent Exclusion Criteria: 1. Diagnosis with a moderate or severe brain injury 2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g., cardiac condition, clotting disorder, pulmonary condition, etc. 3. Ankle weakness resulting from spinal cord injury or central nervous system pathology 4. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity 5. Rheumatoid or inflammatory arthritis 6. Necrosis of any bones in the foot or ankle 7. Pain of 8/10 or greater during walking 8. Uncorrected visual or hearing impairments 9. Require use of a knee stabilizing device to perform daily activities (i.e., Knee ankle foot orthosis, knee orthosis, etc.) 10. Pregnancy 11. Body mass index greater than 40 kg/m2

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As listed by the trial registrant

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

Traumatic lower limb injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States