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

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.

Study Overview

• Status: Recruiting
• Conditions: Wounds and Injuries; Extremity Injury; Wounds; Amputation, Traumatic/Surgery; Open Fracture Wounds; Traumatic Wounds and Injuries; Amputation, Wound
• Intervention / Treatment: Procedure: Standard of Care (SOC); Device: Clinical Decision Support Tool

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, even when treated with aggressive surgical interventions, including debridement every 2-3 days. This pilot trial uses WounDx™, a device that aids clinicians in identifying extremity wounds that are likely to heal after surgical closure. The device is a Clinical Decision Support Tool (CDST) and consists of two main components: an immunoassay to obtain the expression of inflammatory biomarkers and, together with clinical data input, an interpretative algorithm. The purpose of the device is to identify wounds likely to proceed through normal phases of wound healing and, as a result, provide the clinician with a wound-specific prediction that an open traumatic extremity wound will heal successfully and remain closed if delayed closure is performed. The pilot trial serves as a proof of concept (POC) trial and establishes the overall feasibility of clinical operations (including recruitment, randomization, implementation of the intervention, and data collection). Trial enrollment is planned only for adults (≥18 to ≤65 years) with at least one traumatic extremity wound ≥75cm 2 , being treated with Negative Wound Pressure Therapy (NPWT), and delayed primary closure including split thickness skin grafting and rotational or free flaps. Local and systemic inflammatory biomarker expression will be assessed in wound effluent samples collected during subject treatment. These results will be input with other associated clinical data to WounDx™ to allow the device to provide a report including a recommendation on whether a specific wound should be closed within 48-72h of the previous debridement surgery, which is consistent with the current clinical practice guidelines. This pilot trial will inform the conduct of a larger, pivotal clinical trial to evaluate the safety and efficacy of WounDx™ in aiding clinicians identify traumatic extremity wounds ready for surgical closure.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Elster, MD; Phone Number: 301-295-3017; Email: eric.elster@usuhs.edu
• Study Contact Backup: Name: Seth Schobel, PhD; Phone Number: 301-295-3164; Email: seth.schobel-mchugh@usuhs.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Not yet recruiting
      • University of Alabama - Birmingham Hospital
      • Contact: Rondi Gelbard, MD; Phone Number: 205-975-3030; Email: rgelbard@uabmc.edu
      • Contact: Joel Rodgers; Phone Number: 205-515-3590; Email: jrodgers@uabmc.edu
      • Principal Investigator: Rondi Gelbard, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University / Grady Memorial Hospital
      • Contact: Christopher Dente, MD; Phone Number: 404-251-8915; Email: cdente@emory.edu
      • Contact: Elizabeth Dee; Phone Number: 404-251-8912; Email: esitek@emory.edu
      • Principal Investigator: Christopher Dente, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Not yet recruiting
      • Indiana University Health University Hospital
      • Contact: Luke Lopas, MD; Phone Number: 317-944-9400; Email: llopas@iuhealth.org
      • Contact: Lauren Hill; Phone Number: 314-496-0604; Email: hillc@iu.edu
      • Principal Investigator: Luke Lopas, MD
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Hospital
      • Contact: Joseph F Moure, MD; Phone Number: 919-681-8799; Email: joseph.fernandezmoure@duke.edu
      • Contact: Allyn Damman; Phone Number: 919-259-4414; Email: allyn.meredith@duke.edu
      • Principal Investigator: Joseph F Moure, MD
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Not yet recruiting
      • Brooke Army Medical Center
      • Contact: Zachary Roward, MD; Phone Number: 210-916-3400; Email: zachary.t.roward.mil@health.mil
      • Principal Investigator: Zachary Roward, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Standard of Care (SOC); The standard of care consists of serial wound irrigation, negative pressure wound therapy, and surgical debridement; Other Names: Serial Wound Irrigation; Negative Wound Pressure Therapy; Surgical Debridement
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.	Device: Clinical Decision Support Tool; WounDx is a clinical decision support tool that will help augment the clinicians' judgment regarding the wounds readiness to close.; Other Names: WounDx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: University of Alabama at Birmingham; Emory University; Duke University; Uniformed Services University of the Health Sciences; Brooke Army Medical Center; Indiana University Health; Grady Memorial Hospital
• Investigators: Principal Investigator: Eric Elster, MD, Uniformed Services University of the Health Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 21, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): September 20, 2026

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Wounds; Clinical Decision Support Tool; Extremity Injury; Delayed Wound Closure; Cytokine Biomarkers; Wound Effluent; Traumatic Extremity Wounds
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Surgical Procedures, Operative; Quality of Health Care; Quality Indicators, Health Care; Drainage; Wound Closure Techniques; Standard of Care; Negative-Pressure Wound Therapy
• Other Study ID Numbers: Pro00117915; HU0001-23-2-0030 (Other Identifier: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes