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Pilot Trial for WounDx™ Clinical Decision Support Tool
SC2i-WounDx-001-WounDx™ Pilot Trial: Proof of Concept Feasibility for the Clinical Operations of WounDx™ in Aiding Clinicians Identify Wounds That Are Ready For Surgical Closure
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * Insulin Dependent Diabetes * Peripheral Vascular Disease * Connective Tissue Disorders * Preexisting immunosuppressive conditions or immunosuppression therapy * Pregnancy * Prisoners
About the study
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.
What is being tested
- Clinical Decision Support Tool (device)
- Standard of Care (SOC) (procedure)
Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Participants: 40 · Started: May 1, 2026
Contact the study team
- Eric Elster, MD · Phone: 301-295-3017
- Seth Schobel, PhD · Phone: 301-295-3164
Official record on ClinicalTrials.gov — NCT06921707
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.