WounDx device to help guide delayed closure of large traumatic limb wounds
Official title: 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
Run by Henry M. Jackson Foundation for the Advancement of Military Medicine · NCT06921707 · Data updated 2026-11-12
This pilot tests whether the WounDx device can help surgeons decide when delayed closure will successfully heal large traumatic extremity wounds in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Henry M. Jackson Foundation for the Advancement of Military Medicine Academic / other |
| Locations | 5 sites (Birmingham, Alabama and 4 other locations) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | September 20, 2026 |
| Study ends | September 20, 2026 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT06921707 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with at least one traumatic extremity wound of ≥75 cm2 being treated with negative pressure wound therapy and planned delayed primary closure (including grafts or flaps) are the ideal candidates.
✕Probably not a fit
People with insulin-dependent diabetes, peripheral vascular disease, connective tissue disorders, significant immunosuppression, pregnant people, or prisoners are excluded and would not be expected to benefit from this pilot.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The WounDx device combines a wound immunoassay for inflammatory biomarkers with a clinical-data algorithm to generate a wound-specific report that surgeons can use to guide timing of delayed closure. In this pilot interventional trial, adults with traumatic extremity wounds ≥75 cm2 treated with negative pressure wound therapy and planned delayed primary closure are assigned to WounDx-guided care or standard of care. The device report is provided to the surgeon while the final decision to close remains with the treating clinician, and clinical outcomes plus feasibility metrics (recruitment, randomization, intervention delivery, and data collection) are recorded. Results from this proof-of-concept pilot will inform the design of a larger pivotal trial.
Why it matters
Potential benefit: If successful, WounDx could help surgeons reduce failed delayed closures by providing a wound-specific prediction of healing readiness.
How similar studies have gone: Biomarker-driven clinical decision support for timing wound closure is an emerging approach with limited published clinical evidence, so this pilot is largely a proof-of-concept.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Alabama - Birmingham Hospital
Birmingham, Alabama, United States Recruiting -
Emory University / Grady Memorial Hospital
Atlanta, Georgia, United States Recruiting -
Indiana University Health University Hospital
Indianapolis, Indiana, United States Recruiting -
Duke University Hospital
Durham, North Carolina, United States Recruiting -
Brooke Army Medical Center
Fort Sam Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Eric Elster, MD — Uniformed Services University of the Health Sciences
- Study coordinator: Eric Elster, MD
- Email: eric.elster@usuhs.edu
- Phone: 301-295-3017
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.