Pilot Trial for WounDx™ Clinical Decision Support Tool

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study ID
NCT06921707
Status
Recruiting
Apply to this trial

Conditions

  • Amputation, Traumatic/Surgery
  • Amputation, Wound
  • Extremity Injury
  • Open Fracture Wounds
  • Traumatic Wounds and Injuries
  • Wounds
  • Wounds and Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Clinical Decision Support Tool — DEVICE
    WounDx is a clinical decision support tool that will help augment the clinicians' judgment regarding the wounds readiness to close.
  • Standard of Care (SOC) — PROCEDURE
    The standard of care consists of serial wound irrigation, negative pressure wound therapy, and surgical debridement

Study Details

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.

Key Dates

Start date
Mar 21, 2026
Status verified
Apr 2026
Primary completion
Jun 20, 2026
Completion
Sep 20, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Active Comparator: Standard of Care
    This is the control group that receives the standard of care of serial wound irrigation, Negative Pressure Wound Therapy, and surgical debridement with the attending clinician determining if a wound is ready to close.
  • Experimental: WounDx
    This is the intervention group that receives standard of care plus the WounDx™ report to augment the clinicians' judgment regarding the wounds readiness to close.

Primary Outcome Measure

Number of Patients from Each Site that Completes the Exploratory Outcome Measures [ Time Frame: 1 year ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama - Birmingham HospitalBirminghamAlabama35294
Rondi Gelbard, MD
[email protected]
205-975-3030
Joel Rodgers
[email protected]
205-515-3590
Rondi Gelbard, MD (PRINCIPAL_INVESTIGATOR)
Emory University / Grady Memorial HospitalAtlantaGeorgia30322
Christopher Dente, MD
[email protected]
404-251-8915
Elizabeth Dee
[email protected]
404-251-8912
Christopher Dente, MD (PRINCIPAL_INVESTIGATOR)
Indiana University Health University HospitalIndianapolisIndiana46202
Luke Lopas, MD
[email protected]
317-944-9400
Lauren Hill
[email protected]
314-496-0604
Luke Lopas, MD (PRINCIPAL_INVESTIGATOR)
Duke University HospitalDurhamNorth Carolina27705
Joseph F Moure, MD
[email protected]
919-681-8799
Allyn Damman
[email protected]
919-259-4414
Joseph F Moure, MD (PRINCIPAL_INVESTIGATOR)
Brooke Army Medical CenterFort Sam HoustonTexas78234
Zachary Roward, MD
[email protected]
210-916-3400
Zachary Roward, MD (PRINCIPAL_INVESTIGATOR)

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University of Alabama - Birmingham Hospital· Birmingham, ALEmory University / Grady Memorial Hospital· Atlanta, GAIndiana University Health University Hospital· Indianapolis, INDuke University Hospital· Durham, NCBrooke Army Medical Center· Fort Sam Houston, TX

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