NCT06921707 · Henry M. Jackson Foundation for the Advancement of Military Medicine
Pilot Trial for WounDx™ Clinical Decision Support Tool
What this study is about
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.
View original scientific description
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.
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
Primary outcome measures
Number of Patients from Each Site that Completes the Exploratory Outcome Measures
Time frame: 1 year
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Atlanta, Georgia
- Indianapolis, Indiana
- Durham, North Carolina
- Fort Sam Houston, Texas
Collaborators
Duke University, University of Alabama at Birmingham, Brooke Army Medical Center, Grady Memorial Hospital, Indiana University Health, Uniformed Services University of the Health Sciences, Emory University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 17, 2026 · Source of record for eligibility and locations