Pilot Trial for WounDx™ Clinical Decision Support Tool

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

Interventions

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.

PROCEDURE

Standard of Care (SOC)

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

Sponsors & Collaborators

• Duke University

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Brooke Army Medical Center

  collaborator FED

• Grady Memorial Hospital

  collaborator OTHER

• Indiana University Health

  collaborator OTHER

• Uniformed Services University of the Health Sciences

  collaborator FED

• Emory University

  collaborator OTHER

• Henry M. Jackson Foundation for the Advancement of Military Medicine

  lead OTHER

Principal Investigators

• Eric Elster, MD · Uniformed Services University of the Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-21

Primary Completion

2026-06-20

Completion

2026-09-20

FDA Device

Yes

Countries

• United States

Study Locations