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New Wound-Reading device could help surgeons close at the right time

NCT ID NCT06921707

Diagnosis Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 31, 2026 · Updated 5 times

Summary

This pilot study tests a new device called WounDx that gives surgeons information about a wound to help them decide when it's ready to be surgically closed. The study will enroll 40 people with large extremity wounds. The goal is to see if the device can be used smoothly in a hospital setting, not yet to prove it improves outcomes.

What this could mean

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

Active substance
WounDx clinical decision support tool
What this could lead to
If successful, WounDx could help surgeons more accurately decide when to close wounds, potentially reducing complications and improving healing.
What could go wrong
This is a very small pilot study (40 people) focused on feasibility, not on proving the device works. The device is experimental and not yet FDA-approved.

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 40 people

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

Started

May 2026

Expected to finish

Sep 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: * Wound surface area ≥75cm 2 * Extremity injury (including shoulder and buttock - without visceral communication) * Wound amenable to Negative Pressure Wound Therapy using 3M™ V.A.C. ® canisters without gel pack Exclusion Criteria: * Insulin Dependent Diabetes * Peripheral Vascular Disease * Connective Tissue Disorders * Preexisting immunosuppressive conditions or immunosuppression therapy * Pregnancy * Prisoners

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Conditions

The condition(s) this trial relates to.

injury

As listed by the trial registrant

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

Amputation, traumatic/surgery Amputation, wound Extremity injury Open fracture wounds Traumatic wounds and injuries Wounds Wounds and injuries

How to take part

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

  1. The places running it

    5 sites. 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

  • Brooke Army Medical Center

    RECRUITING

    Fort Sam Houston, Texas, 78234, United States

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Emory University / Grady Memorial Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Indiana University Health University Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • University of Alabama - Birmingham Hospital

    RECRUITING

    Birmingham, Alabama, 35294, United States

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