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Can pressurized oxygen help heal infected broken bones?

NCT ID NCT07535164

Disease control Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether adding hyperbaric oxygen therapy (breathing pure oxygen in a pressurized chamber) to standard surgery and antibiotics is feasible for treating infected leg fractures. Fifty adults with confirmed or suspected infection will be randomly assigned to receive either standard care alone or standard care plus hyperbaric oxygen. The main goal is to see if a larger trial is possible, not yet to prove the treatment works.

What this could mean

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

Active substance
hyperbaric oxygen therapy (breathing pure oxygen at high pressure)
What this could lead to
If successful, this could pave the way for a larger trial that may show hyperbaric oxygen helps control infections in broken bones.
What could go wrong
This is a small pilot study (50 people) testing feasibility, not effectiveness. It is early-stage and may not lead to a proven 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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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 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 * Confirmed or highly suspected post-traumatic FRI of the lower limb, for which surgical intervention will be conducted Exclusion Criteria: * Patients with a known contraindication for HBOT: untreated pneumothorax; epilepsy; middle ear or thorax surgery in the previous 12 months; inability to equalize the ears; COPD grade 4 or other severe air trapping lung disease; presence of a device that is not known to be compatible with HBOT; severe claustrophobia; pregnancy; BMI ≥ 35; obstructive sleep apnoea syndrome or obesity hypoventilation syndrome with a chronic increased PaCO2 \> 6.4 kPa * Patients with an early (i.e. diagnosed \<6 weeks post initial trauma) FRI, which is treated by DAIR-procedure (Debridement, Antibiotics, Implant Retention) without soft tissue reconstruction * Patients with an active isolation precautions protocol which is incompatible with treatment in a hyperbaric chamber (i.e. with multiple patients in the chamber at the same time) * Inability to understand Dutch or English

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As listed by the trial registrant

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

Fracture related infection Hyperbaric oxygenation

How to take part

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  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

  • Amsterdam UMC

    Amsterdam, North Holland, 1105AZ, Netherlands

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