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Speed saves limbs: trial tests 72-Hour flap surgery for crushed legs

NCT ID NCT06293469

Disease control Sponsor: Johns Hopkins University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 1 time

Summary

This study compares getting flap surgery within 72 hours of a severe leg injury versus waiting longer. The goal is to see if faster surgery reduces death, amputation, infections, and hospital stays. About 356 adults with open fractures or dislocations below the knee will take part.

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 356 people

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

Started

Nov 2024

Expected to finish

Feb 2030

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.

The inclusion criteria are: 1. Patients 18 years of age or older. 2. Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury. 3. Will have all planned flap surgeries performed by a participating surgeon or delegate. 4. Able to be randomized within 48 hours of injury. The exclusion criteria are: 1. Site is unable to implement the accelerated flap protocol due to local logistics. 2. Primary amputation anticipated prior to attempted flap for management of the injury. 3. Critical limb ischemia that requires re-vascularization for limb perfusion. 4. Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery. 5. Burns at the musculoskeletal injury site. 6. Incarceration. 7. Expected injury survival of less than 12 months. 8. Terminal illness with expected survival of less than 12 months. 9. Currently enrolled in a trial that does not permit co-enrollment. 10. Declined to provide informed consent. 11. Unable to obtain informed consent due to language barriers. 12. Unable to obtain informed consent because a legally authorized representative was unavailable. 13. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient. 14. Prior enrollment in the trial. 15. Eligible patient or LAR was not approached within screening window (missed participant). 16. Other reason to exclude the patient, as approved by the Principal Investigators.

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Conditions

The condition(s) this trial relates to.

bone fracture Leg Injuries tibia fracture

As listed by the trial registrant

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

Extremity fracture lower Extremity injuries lower Open dislocation of ankle Open tibia fracture

How to take part

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

  1. The places running it

    11 sites in 4 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

  • John Hopkins Bayview Medical Center

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • R Adams Cowley Shock Trauma Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Saint John Regional Hospital

    RECRUITING

    Saint John, New Brunswick, E2L 4L2, Canada

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • The Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • UC Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Maryland Capital Region Medical Center

    RECRUITING

    Largo, Maryland, 20774, United States

  • Vall d'Hebron University Hospital

    RECRUITING

    Barcelona, 08035, Spain

  • Vancouver General Hospital

    RECRUITING

    Vancouver, British Columbia, V5Z 1N1, Canada

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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Other studies related to the condition(s) this trial covers.