Pilot Trial for WounDx™ Clinical Decision Support Tool

NCT06921707 | Recruiting DMC FDA Device

• 2 other identifiers: Pro00117915HU0001-23-2-0030
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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; Amputation, Wound; Open Fracture Wounds

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients from Each Site that Completes the Exploratory Outcome Measures

  The primary outcome will be a report detailing the total number of patients from each site who have successfully completed all exploratory outcome measures. It is expected that a minimum of 3 patients from each site will complete required exploratory outcome measures.

  1 year

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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.

Procedure: Standard of Care (SOC)

WounDx

EXPERIMENTAL

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.

Device: Clinical Decision Support Tool

Interventions

Clinical Decision Support Tool DEVICE

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

Also known as: WounDx

WounDx

Standard of Care (SOC) PROCEDURE

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

Also known as: Serial Wound Irrigation, Negative Wound Pressure Therapy, Surgical Debridement

Standard of Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Grady Memorial Hospital: collaborator
• Indiana University Health: collaborator
• Uniformed Services University of the Health Sciences: collaborator
• Emory University: collaborator
• Duke University: collaborator
• University of Alabama at Birmingham: collaborator
• Brooke Army Medical Center: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead

Study Sites (5)

University of Alabama - Birmingham Hospital

Birmingham, Alabama, 35294, United States

NOT YET RECRUITING

Emory University / Grady Memorial Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

Duke University Hospital

Durham, North Carolina, 27705, United States

RECRUITING

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

NOT YET RECRUITING

Related Publications (4)

• Peoples GE, Jezior JR, Shriver CD. Caring for the wounded in Iraq--a photo essay. N Engl J Med. 2004 Dec 9;351(24):2476-80. doi: 10.1056/NEJMp048327. No abstract available.

  PMID: 15622566 BACKGROUND

• Owens BD, Kragh JF Jr, Wenke JC, Macaitis J, Wade CE, Holcomb JB. Combat wounds in operation Iraqi Freedom and operation Enduring Freedom. J Trauma. 2008 Feb;64(2):295-9. doi: 10.1097/TA.0b013e318163b875.

  PMID: 18301189 BACKGROUND

• Montgomery SP, Swiecki CW, Shriver CD. The evaluation of casualties from Operation Iraqi Freedom on return to the continental United States from March to June 2003. J Am Coll Surg. 2005 Jul;201(1):7-12; discussion 12-3. doi: 10.1016/j.jamcollsurg.2005.03.038.

  PMID: 15978435 BACKGROUND

• Lisboa FA, Dente CJ, Schobel SA, Khatri V, Potter BK, Kirk AD, Elster EA. Utilizing Precision Medicine to Estimate Timing for Surgical Closure of Traumatic Extremity Wounds. Ann Surg. 2019 Sep;270(3):535-543. doi: 10.1097/SLA.0000000000003470.

  PMID: 31348045 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Standard of Care; Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Eric Elster, MD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Elster, MD

CONTACT

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

Seth Schobel, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial design, is a parallel group randomized controlled study where participants are randomized to either 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, or the interventional group that receives standard of care plus the WounDx™ report to augment the clinicians' judgment regarding the wounds readiness to close.

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: March 21, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)