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Pilot Trial for WounDx™ Clinical Decision Support Tool

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 30, 2026 (before its estimated September 20, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 3 months later Jun 20, 2026 → Sep 20, 2026
See other at-risk trials from Henry M. Jackson Foundation for the Advancement of Military Medicine

Record History

  1. Site details revised at 1 of 5 sitesv9
  2. Primary completion pushed from Jun 20, 2026 to Sep 20, 2026
    • Start date changed from estimate of Mar 21, 2026 to May 1, 2026
    • Site details revised at 2 of 5 sites
    v8
  3. Recruitment opened
    • Site details revised at 5 of 5 sites
    v7
  4. Start date: Dec 21, 2025 to Mar 21, 2026
    • Primary completion date: Mar 20, 2026 to Jun 20, 2026
    • Study completion date: Jun 20, 2026 to Sep 20, 2026
    v6
  5. Start date: Nov 21, 2025 to Dec 21, 2025v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Jul 21, 2025 to Nov 21, 2025v4
  2. Start date: Jun 20, 2025 to Jul 21, 2025
    • Site details revised at 1 of 5 sites
    v3
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this research is to evaluate the overall use of the WounDx medical device in a clinical setting, such as a hospital. The WounDx device is experimental and not yet approved by the United States Food and Drug Administration (FDA). WounDx uses information about a patient's wound to generate a report that a surgeon may use to help determine when to close or not close the wound. The final decision to close the wound remains with the surgeon. The results from this pilot trial will inform a larger pivotal trial.
Trial Details
NCT Number NCT06921707
Lead Sponsor Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators: Duke University, University of Alabama at Birmingham, Brooke Army Medical Center, Grady Memorial Hospital, Indiana University Health, Uniformed Services University of the Health Sciences, Emory University
Conditions
(from sponsor)		 Wounds, Wounds and Injuries, Extremity Injury, Traumatic Wounds and Injuries, Amputation, Traumatic/Surgery, Amputation, Wound, Open Fracture Wounds
Related terms Wounds and Injuries
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov