Recruiting

WounDx

Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Code:

NCT06921707

Conditions

Wounds

Wounds and Injuries

Extremity Injury

Traumatic Wounds and Injuries

Amputation, Traumatic/Surgery

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Clinical Decision Support Tool

Standard of Care (SOC)

Study Details

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 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

Wounds

Wounds and Injuries

Extremity Injury

Traumatic Wounds and Injuries

Amputation, Traumatic/Surgery

Study ID

NCT06921707

Start date

May 1, 2026

Status verified date

Jul, 2026

Completion date

Sep 20, 2026

Anticipated

Primary completion date

Sep 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

active comparator: Standard of Care

This is the control group that receives the standard of care of serial wound irrigation, Negative Pressure Wound Therapy, and surgical debridement with the attending clinician determining if a wound is ready to close.

experimental: WounDx

This is the intervention group that receives standard of care plus the WounDx™ report to augment the clinicians' judgment regarding the wounds readiness to close.

Interventions

Clinical Decision Support Tool

WounDx is a clinical decision support tool that will help augment the clinicians' judgment regarding the wounds readiness to close.

Standard of Care (SOC)

The standard of care consists of serial wound irrigation, negative pressure wound therapy, and surgical debridement

Primary outcome measure

  • Number of Patients from Each Site that Completes the Exploratory Outcome Measures [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Eric Elster, MD

301-295-3017eric.elster@usuhs.edu

Seth Schobel, PhD

301-295-3164seth.schobel-mchugh@usuhs.edu

Locations

University of Alabama - Birmingham Hospital

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Rondi Gelbard, MD

205-975-3030rgelbard@uabmc.edu

Joel Rodgers

205-515-3590jrodgers@uabmc.edu

Principal Investigator:

Rondi Gelbard, MD

Emory University / Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Christopher Dente, MD

404-251-8915cdente@emory.edu

Elizabeth Dee

404-251-8912esitek@emory.edu

Principal Investigator:

Christopher Dente, MD

Indiana University Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Luke Lopas, MD

317-944-9400llopas@iuhealth.org

Lauren Hill

314-496-0604hillc@iu.edu

Principal Investigator:

Luke Lopas, MD

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Joseph F Moure, MD

919-681-8799joseph.fernandezmoure@duke.edu

Allyn Damman

919-259-4414allyn.meredith@duke.edu

Principal Investigator:

Joseph F Moure, MD

Brooke Army Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

Zachary Roward, MD

210-916-3400zachary.t.roward.mil@health.mil

Principal Investigator:

Zachary Roward, MD

More Information

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • Wounds
  • Extremity Injury
  • Clinical Decision Support Tool
  • Delayed Wound Closure
  • Cytokine Biomarkers
  • Wound Effluent
  • Traumatic Extremity Wounds

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine on 2026-07-30.