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PET scans put to the test for diabetic foot bone infections

NCT ID NCT07828691

Diagnosis Sponsor: Jewish General Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Diabetic foot osteomyelitis is a bone infection that can lead to amputation, and it is hard to diagnose. This study checks how accurately 18F-FDG PET/CT scans detect the infection in people with diabetes who are already referred for this imaging. Researchers compare scan results with bone biopsy or with clinical and imaging follow-up over at least six months.

What this could mean

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

Active substance
18F-FDG PET/CT imaging of the feet
What this could lead to
If the scan proves accurate, doctors could use it to spot bone infections in diabetic feet earlier and avoid unnecessary surgery or antibiotics.
What could go wrong
The scan may miss small infections or flag harmless inflammation as infection. This is an observational accuracy study, so it cannot prove that using the scan improves patient 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.

Participants

About 150 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

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

Adults with diabetes and suspected diabetic foot infection with concern for osteomyelitis who have been referred by their treating physician for 18F-FDG PET/CT at participating academic centers in Canada and the United States. Approximately 150 consecutive eligible participants will be prospectively enrolled. Clinical care, including the decision to perform bone biopsy or other investigations and treatments, will remain at the discretion of the treating physicians.

Ages

18 years and older

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: Age ≥18 years Diagnosis of diabetes mellitus Referred by the treating physician for clinically indicated 18F-FDG PET/CT of the foot for diabetic foot infection with concern for possible osteomyelitis Exclusion Criteria: History of previous bone infection in the study foot within the past 6 months Congenital bone disease such as osteogenesis imperfecta Active pregnancy Recent surgery in the foot with suspected osteomyelitis within the past 6 months Inability to provide informed consent or undergo PET/CT imaging

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

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

Diabetic foot infections

How to take part

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

  1. The places running it

    4 sites in 2 countries. 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

  • Hôpital du Sacré-Cœur de Montréal

    Montreal, Canada

  • Jewish General Hospital

    Montreal, Canada

  • McGill University Health Centre

    Montreal, Canada

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States