Pilot Trial for WounDx™ Clinical Decision Support Tool
Recruiting now · Not applicable
Conditions studied: Wounds, Wounds and Injuries, Extremity Injury, Traumatic Wounds and Injuries, Amputation, Traumatic/Surgery, Amputation, Wound, Open Fracture Wounds
In brief
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 facts
- Study ID
- NCT06921707
- Run by
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- People needed
- 40
- Starts
- 2026-05-01
- Expected to finish
- 2026-09-20
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Insulin Dependent Diabetes
- Peripheral Vascular Disease
- Connective Tissue Disorders
- Preexisting immunosuppressive conditions or immunosuppression therapy
- Pregnancy
- Prisoners
Where it is running
- University of Alabama - Birmingham Hospital — Birmingham, Alabama, United States (enrolling)
- Emory University / Grady Memorial Hospital — Atlanta, Georgia, United States (enrolling)
- Indiana University Health University Hospital — Indianapolis, Indiana, United States (enrolling)
- Duke University Hospital — Durham, North Carolina, United States (enrolling)
- Brooke Army Medical Center — Fort Sam Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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