Status:
NOT_YET_RECRUITING
Pilot Trial for WounDx™ Clinical Decision Support Tool
Lead Sponsor:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborating Sponsors:
Duke University
University of Alabama at Birmingham
Conditions:
Wounds
Wounds and Injuries
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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...
Detailed Description
Determining if a large, traumatic extremity wound is ready for successful delayed closure remains a challenge, as approximately 23%-25% of these wounds fail to heal after delayed closure is attempted,...
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
Key Trial Info
Start Date :
December 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06921707
Start Date
December 21 2025
End Date
June 20 2026
Last Update
November 19 2025
Active Locations (5)
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1
University of Alabama - Birmingham Hospital
Birmingham, Alabama, United States, 35294
2
Emory University / Grady Memorial Hospital
Atlanta, Georgia, United States, 30322
3
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202
4
Duke University Hospital
Durham, North Carolina, United States, 27705