Pilot Trial for WounDx™ Clinical Decision Support Tool

This study is testing a new medical device called WounDx™ (pronounced "wound-dex"). WounDx™ is a Clinical Decision Support Tool (CDST) that helps doctors decide if a large wound on an arm or leg is ready to be closed. It works by looking at information from your wound to create a report for the surgeon. The final decision to close the wound is always made by the surgeon. This trial will help us understand how well WounDx™ works in a hospital setting and if it can help improve wound healing. We are looking for 40 participants, aged 18 to 65, with large extremity wounds. The main goal is to see how many patients complete the study's measurements over one year.

Study design
This is an interventional pilot trial with a planned enrollment of 40 participants. It is testing the WounDx device alongside standard wound care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year to measure the number of patients who complete the exploratory outcome measures.

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NCT06921707

Pilot Trial for WounDx™ Clinical Decision Support Tool

Recruiting
NAAges 18–65InterventionalDevice feasibility
Henry M. Jackson Foundation for the Advancement of Military Medicine
~40 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Clinical Decision Support ToolStandard of Care (SOC)

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Patients from Each Site that Completes the Exploratory Outcome Measures
Measured over 1 year
Wounds
Wounds and Injuries
Extremity Injury
Traumatic Wounds and Injuries
Amputation, Traumatic/Surgery
Amputation, Wound
Open Fracture Wounds
5 sites across 5 states
Alabama1
Georgia1
Indiana1
North Carolina1
Texas1
  • Eric Elster, MD · PRINCIPAL_INVESTIGATOR · Uniformed Services University of the Health Sciences

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Eligibility criteria

Inclusion

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

Insulin Dependent Diabetes
Peripheral Vascular Disease
Connective Tissue Disorders
Preexisting immunosuppressive conditions or immunosuppression therapy
Pregnancy
Prisoners
  • Number of Patients from Each Site that Completes the Exploratory Outcome Measures1 year

    The primary outcome will be a report detailing the total number of patients from each site who have successfully completed all exploratory outcome measures. It is expected that a minimum of 3 patients from each site will complete required exploratory outcome measures.