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Researchers track nerve pain in ankle fracture patients

NCT ID NCT06420141

Knowledge-focused Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 250 people who had ankle fractures to see how many develop nerve-related chronic pain after the bone heals. Participants answer pain questionnaires and undergo simple sensory tests. The goal is to better understand this type of pain, not to test any new treatment.

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.

Participants

About 250 people

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

Started

Jan 2024

Expected to finish

Dec 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.

Who is studied

The investigators will enroll participants who have sustained rotational ankle (specifically AO/OTA 44 types AC) fractures that are treated operatively. Fracture patients will complete clinic assessment sessions at standard of care visits, including their first post-op appointment (2-3 weeks), at 6-8 weeks, at 3-4 months, and at 6-9 months post-operatively. These visits will allow assessments during the subacute and chronic stages of bone fracture associated neuropathic pain.

Ages

18 to 85 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.

Fracture Group: Inclusion Criteria: 1. 18-85 years old 2. an isolated rotational ankle (AO/OTA 44 types A-C) fracture that is treated operatively 3. Abbreviated Injury Scale \< 3 for non-extremity body systems 4. can speak, read, and understand English Exclusion Criteria: 1. treated for a chronic pain condition prior to their qualifying injury 2. on a pain contract 3. pathologic fracture 4. Daily use of gabapentin or opiods prior to enrollment Control Group: Inclusion Criteria: 1. 18-85 years of age 2. can speak, read, and understand English Exclusion Criteria: 1. Chronic pain or an ongoing acute pain condition 2. Currently or have previously sustained a bone fracture 3. Current Pain medication usage 4. Any previous orthopaedic surgical procedures 5. Must have been free of any surgeries for at least 5 years 6. Peripheral neuropathy 7. Individuals having had a major surgery or a major disease or condition, as determined by the PI, such as cardiovascular disease, metabolic disorders, renal disease, neurological disorders, or severe psychiatric conditions.

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Conditions

The condition(s) this trial relates to.

neuralgia

As listed by the trial registrant

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

Neuropathic pain

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

  • Indiana University School of Medicine

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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