Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06921707

Pilot Trial for WounDx™ Clinical Decision Support Tool

Led by Henry M. Jackson Foundation for the Advancement of Military Medicine · Updated on 2026-04-17

40

Participants Needed

5

Research Sites

26 weeks

Total Duration

On this page

Sponsors

H

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

D

Duke University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pilot Trial for WounDx™ Clinical Decision Support Tool

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Wound surface area 75 cm2 or larger
  • Extremity injury including shoulder and buttock without visceral communication
  • Wound suitable for Negative Pressure Wound Therapy using 3M V.A.C. canisters without gel pack
Not Eligible

You will not qualify if you...

  • Insulin dependent diabetes
  • Peripheral vascular disease
  • Connective tissue disorders
  • Preexisting immunosuppressive conditions or immunosuppression therapy
  • Pregnancy
  • Prisoners

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

University of Alabama - Birmingham Hospital

Birmingham, Alabama, United States, 35294

Not Yet Recruiting

2

Emory University / Grady Memorial Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

3

Indiana University Health University Hospital

Indianapolis, Indiana, United States, 46202

Not Yet Recruiting

4

Duke University Hospital

Durham, North Carolina, United States, 27705

Actively Recruiting

5

Brooke Army Medical Center

Fort Sam Houston, Texas, United States, 78234

Not Yet Recruiting

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Research Team

E

Eric Elster, MD

CONTACT

S

Seth Schobel, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

2

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