Clinical Decision Support Tool for Wounds

Not yet recruiting at 5 trial locations

Overseen By Seth Schobel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Must not be taking: Immunosuppressants

Disqualifiers: Diabetes, Vascular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 48-72 hours per debridement cycle, ongoing for up to 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well a new tool, WounDx, assists doctors in deciding when to close a wound. WounDx provides additional information about a patient's wound, potentially aiding better decision-making in a hospital setting. The trial compares patients receiving standard care treatments with those who also receive a report from the WounDx tool. Individuals with large wounds on their limbs, who do not have conditions like diabetes requiring insulin, might be suitable candidates. The findings will inform the planning of a larger trial in the future. As an unphased trial, this study allows patients to contribute to early-stage research that could enhance wound care decisions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the WounDx device is safe for use in a clinical setting?

Research has shown that specific safety information for the WounDx™ Clinical Decision Support Tool is not yet available. This tool remains under testing and lacks FDA approval. It is designed to assist doctors in determining when a wound might be ready to close by providing a report based on the wound's condition.

As a tool, not a medication or surgery, its safety concerns differ. The focus is on its effectiveness in aiding doctors' decisions, rather than on side effects. Thus, there are no typical "side effects" like those from medications. Instead, the tool aims to support safe and effective wound care decisions.

The trial, currently in an early phase, helps researchers understand the tool's function in real medical settings. This stage is crucial for ensuring the tool's safety and usefulness before progressing to larger trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WounDx™ Clinical Decision Support Tool because it offers a new way to enhance wound care. Unlike the standard of care—which typically involves serial wound irrigation, Negative Pressure Wound Therapy, and surgical debridement—WounDx™ provides a tailored report that augments a clinician's judgment on when a wound is ready to close. This personalized approach could lead to more accurate and timely wound management, potentially improving healing outcomes and reducing recovery time. By integrating data-driven insights, WounDx™ aims to optimize decisions for wound closure, offering a significant improvement over conventional methods.

What evidence suggests that the WounDx device is effective for wound management?

This trial will compare the use of the WounDx™ Clinical Decision Support Tool with standard care for wound management. Studies have shown that tools like WounDx can boost doctors' confidence in assessing and treating wounds. Research indicates that these tools make wound evaluations more consistent, leading to better healing. The WounDx tool provides a report that helps doctors determine when a wound might be ready to close, potentially improving wound care decisions. Although WounDx is still being tested in this trial, similar tools have improved wound management in various settings. Early evidence suggests that this approach could be helpful in clinical environments. ^{1 3 4 6 7}

Who Is on the Research Team?

Eric Elster, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Are You a Good Fit for This Trial?

This trial is for individuals with large wounds (≥75cm2) from injuries like amputations or open fractures, specifically on extremities including shoulders and buttocks. The wound must be suitable for Negative Pressure Wound Therapy without gel packs.

Inclusion Criteria

My wound can be treated with a specific vacuum-assisted closure device.

My wound is larger than 75 square centimeters.

I have an injury to my arm, leg, shoulder, or buttock without internal organ involvement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care with or without the WounDx™ report to aid in determining wound readiness for closure

48-72 hours per debridement cycle, ongoing for up to 1 year

Regular visits for debridement every 2-3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• WounDx™ Clinical Decision Support Tool

Trial Overview The study tests the WounDx device, which isn't FDA-approved yet. It provides reports to help surgeons decide when to close a wound. Participants will receive standard care; some will also use the WounDx tool.

How Is the Trial Designed?

Group I: WounDx Experimental Treatment 1 Intervention

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 II: Standard of Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Recruited

94,300+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

Indiana University Health

Collaborator

Trials

35

Recruited

18,500+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Grady Memorial Hospital

Collaborator

Trials

5

Recruited

8,500+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

A study analyzing the usability of clinical decision support systems (CDSS) for community-acquired pneumonia and neutropenic fever found 422 recorded events, including 3 mistakes that could have been life-threatening, highlighting the critical need for careful design and evaluation of these systems.

Incorporating usability engineering principles early in the design of CDSS can help identify interface issues that may lead to adverse medical events, emphasizing the importance of user-friendly software in improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How usability of a web-based clinical decision support system has the potential to contribute to adverse medical events. Graham, TA., Kushniruk, AW., Bullard, MJ., et al.[2022]

Clinical decision support systems, like Project IMPACT and APACHE III, are essential for managing patient outcomes in critical care by enabling data analysis and predictive modeling.

These tools help clinicians compare actual patient outcomes with predicted outcomes, which can improve quality control and process improvement in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support systems for outcome measurement and management. Sakallaris, BR., Jastremski, CA., Von Rueden, KT.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06921707

Pilot Trial for WounDx™ 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 ...

2. smith-nephew.com smith-nephew.com/en-us/health-care-professionals/products/advanced-wound-management/cdst

TIME clinical decision support tool (CDST) INFOGRAPHIC: How the T.I.M.E. clinical decision support tool (CDST) can help enhance confidence and reduce variation with wound assessment and management: a ...

3. withpower.com withpower.com/trial/phase-amputation-traumatic-5-2025-bc8b6

Clinical Decision Support Tool for Wounds The WounDx™ Clinical Decision Support Tool is unique because it uses a decision-making system to help healthcare providers choose the best materials and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0965206X25000622

Impact on management performance outcomes of ... One of the latest tools developed to help improve wound healing outcomes through standardization of wound care management approaches is T.I.M.E. CDST (Tissue ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12124507/

Impact of digital wound care solution on healing time ... tools to support a standardized assessment approach [20]. ... system continues to optimize wound management across diverse clinical environments.

6. dha.mil dha.mil/News/2025/04/23/16/45/WounDx-Revolutionizing-Wound-Care-to-Improve-Warfighter-Readiness-and-Reduce-Costs

WounDx™: Revolutionizing Wound Care to Improve ... WounDx™ is a biomarker-based clinical decision support tool designed to optimize the timing of wound closure. This software aims to improve care ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482198/

Wound Assessment - StatPearls - NCBI Bookshelf - NIH Accordingly, wound assessment tools are designed to support all qualified nurses in the wound management field in delivering safe and appropriate wound care.