Pilot Trial for WounDx™ Clinical Decision Support Tool

NCT ID: NCT06921707

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-21
• Study Completion Date: 2026-06-20

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.

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.

Conditions

Wounds; Wounds and Injuries; Extremity Injury; Traumatic Wounds and Injuries; Amputation, Traumatic/Surgery; Amputation, Wound; Open Fracture Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Clinical Decision Support Tool

Intervention Type: DEVICE

WounDx is a clinical decision support tool that will help 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.

Intervention Type: DEVICE

Standard of Care (SOC)

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

Intervention Type: PROCEDURE

Other Intervention Names

WounDx; Serial Wound Irrigation; Negative Wound Pressure Therapy; Surgical Debridement

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Brooke Army Medical Center

FED

Sponsor Role: collaborator

Grady Memorial Hospital

OTHER

Sponsor Role: collaborator

Indiana University Health

OTHER

Sponsor Role: collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Elster, MD

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Locations

University of Alabama - Birmingham Hospital

Birmingham, Alabama, United States

Emory University / Grady Memorial Hospital

Atlanta, Georgia, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Duke University Hospital

Durham, North Carolina, United States

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Countries

United States

Central Contacts

Eric Elster, MD

Role: CONTACT

eric.elster@usuhs.edu

301-295-3017

Seth Schobel, PhD

Role: CONTACT

seth.schobel-mchugh@usuhs.edu

301-295-3164

Facility Contacts

Rondi Gelbard, MD

Role: primary

rgelbard@uabmc.edu

205-975-3030

Joel Rodgers

Role: backup

jrodgers@uabmc.edu

205-515-3590

Christopher Dente, MD

Role: primary

cdente@emory.edu

404-251-8915

Elizabeth Dee

Role: backup

esitek@emory.edu

404-251-8912

Luke Lopas, MD

Role: primary

llopas@iuhealth.org

317-944-9400

Lauren Hill

Role: backup

hillc@iu.edu

314-496-0604

Joseph F Moure, MD

Role: primary

joseph.fernandezmoure@duke.edu

919-681-8799

Allyn Damman

Role: backup

allyn.meredith@duke.edu

919-259-4414

Zachary Roward, MD

Role: primary

zachary.t.roward.mil@health.mil

210-916-3400

References

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.

Reference Type: BACKGROUND

PMID: 15622566 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18301189 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15978435 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31348045 (View on PubMed)

Other Identifiers

HU0001-23-2-0030

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00117915

Identifier Type: -

Identifier Source: org_study_id