WoundsNCT06921707
Pilot Trial for WounDx™ Clinical Decision Support Tool
A study testing Clinical Decision Support Tool in people with Wounds and Wounds and Injuries, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Wounds, Wounds and Injuries, Extremity Injury
- What is being tested?
- Clinical Decision Support Tool
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 May 2026to 20 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Insulin Dependent Diabetes
- Peripheral Vascular Disease
- Connective Tissue Disorders
- Preexisting immunosuppressive conditions or immunosuppression therapy
- Pregnancy
- Prisoners
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Emory University / Grady Memorial Hospital
Atlanta, Georgia, 30322
Christopher Dente, MD, 404-251-8915, cdente@emory.edu
Elizabeth Dee, 404-251-8912, esitek@emory.edu
- Recruiting
University of Alabama - Birmingham Hospital
Birmingham, Alabama, 35294
Rondi Gelbard, MD, 205-975-3030, rgelbard@uabmc.edu
Joel Rodgers, 205-515-3590, jrodgers@uabmc.edu
- Recruiting
Duke University Hospital
Durham, North Carolina, 27705
Joseph F Moure, MD, 919-681-8799, joseph.fernandezmoure@duke.edu
Allyn Damman, 919-259-4414, allyn.meredith@duke.edu
- Recruiting
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Zachary Roward, MD, 210-916-3400, zachary.t.roward.mil@health.mil
Zachary Roward, MD
- Recruiting
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Luke Lopas, MD, 317-944-9400, llopas@iuhealth.org
Lauren Hill, 314-496-0604, hillc@iu.edu
About this study
Official title: 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.
Read the 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
- Being tested
- Clinical Decision Support Tool, Standard of Care (SOC)
- Keywords
- Wounds, Extremity Injury, Clinical Decision Support Tool, Delayed Wound Closure, Cytokine Biomarkers, Wound Effluent, Traumatic Extremity Wounds
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support ToolDevice
Also called WounDx
WounDx is a clinical decision support tool that will help augment the clinicians' judgment regarding the wounds readiness to close.
Standard of Care (SOC)Procedure or surgery
Also called Serial Wound Irrigation, Negative Wound Pressure Therapy, Surgical Debridement
The standard of care consists of serial wound irrigation, negative pressure wound therapy, and surgical debridement
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | 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. Receives: Procedure: Standard of Care (SOC) |
| WounDx | Experimental | 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. Receives: Device: Clinical Decision Support Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 May 2026
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial design, is a parallel group randomized controlled study where participants are randomized to either 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, or the interventional group that receives standard of care plus the WounDx™ report to augment the clinicians' judgment regarding the wounds readiness to close.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Eric Elster, MD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921707
- Sponsor's protocol ID
- Pro00117915
- Other IDs
- HU0001-23-2-0030
- Status last verified
- Jul 2026
- First submitted
- 3 Apr 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 15622566Owens 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.
PubMed 18301189Montgomery 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.
PubMed 15978435Lisboa 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.
PubMed 31348045
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06921707
- Acronym / sponsor ID
- Pro00117915
- Conditions
- Wounds, Wounds and Injuries, Extremity Injury, Traumatic Wounds and Injuries, Amputation, Traumatic/Surgery, Amputation, Wound
- Keywords
- Wounds, Extremity Injury, Clinical Decision Support Tool, Delayed Wound Closure, Cytokine Biomarkers, Wound Effluent, Traumatic Extremity Wounds
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- 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
- Study start
- 1 May 2026 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial design, is a parallel group randomized controlled study where participants are randomized to either 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, or the interventional group that receives standard of care plus the WounDx™ report to augment the clinicians' judgment regarding the wounds readiness to close.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Procedure: Standard of Care (SOC)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. |
| WounDx | Experimental | Device: Clinical Decision Support ToolThis is the intervention group that receives standard of care plus the WounDx™ report to augment the clinicians' judgment regarding the wounds readiness to close. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Insulin Dependent Diabetes
- Peripheral Vascular Disease
- Connective Tissue Disorders
- Preexisting immunosuppressive conditions or immunosuppression therapy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision Support ToolAlso: WounDxWounDx is a clinical decision support tool that will help augment the clinicians' judgment regarding the wounds readiness to close. | Device | WounDx |
| Standard of Care (SOC)Also: Serial Wound Irrigation, Negative Wound Pressure Therapy, Surgical DebridementThe standard of care consists of serial wound irrigation, negative pressure wound therapy, and surgical debridement | Procedure or surgery | Standard of Care |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 15622566Peoples 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.
- Background: PubMed 18301189Owens 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.
- Background: PubMed 15978435Montgomery 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.
- Background: PubMed 31348045Lisboa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Elster, MD principal investigator
Uniformed Services University of the Health Sciences
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support Tool in people with Wounds and Wounds and Injuries, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Elster, MD (301-295-3017, eric.elster@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients from Each Site that Completes the Exploratory Outcome Measures (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06921707, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.