[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586924":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":41,"locations":51,"responsibleParty":153,"collaborators":155,"id":169,"slug":170,"hasResults":171,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":45,"eligibilityCriteria":175,"healthyVolunteers":171,"sex":176,"minAge":177,"maxAge":178,"enrollmentInfo":179,"targetDuration":45,"studyType":182,"phases":183,"briefSummary":185,"conditions":186,"keywords":194,"overallStatus":78,"whyStopped":45,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},{"fullName":5,"class":6},"Henry M. Jackson Foundation for the Advancement of Military Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Procedure: Standard of Care (SOC)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Device: Clinical Decision Support Tool",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[15],[15],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Standard of Care (SOC)","The standard of care consists of serial wound irrigation, negative pressure wound therapy, and surgical debridement",[9],[33,34,35],"Serial Wound Irrigation","Negative Wound Pressure Therapy","Surgical Debridement",[37],{"name":38,"affiliation":39,"role":40},"Eric Elster, MD","Uniformed Services University of the Health Sciences","PRINCIPAL_INVESTIGATOR",[42,47],{"name":38,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","301-295-3017",null,"eric.elster@usuhs.edu",{"name":48,"role":43,"phone":49,"phoneExt":45,"email":50},"Seth Schobel, PhD","301-295-3164","seth.schobel-mchugh@usuhs.edu",[52,76,97,117,137],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"University of Alabama - Birmingham Hospital","NOT_YET_RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-86.80249,33.52066,{"lat":64,"lon":63},[67,71,75],{"name":68,"role":43,"phone":69,"phoneExt":45,"email":70},"Rondi Gelbard, MD","205-975-3030","rgelbard@uabmc.edu",{"name":72,"role":43,"phone":73,"phoneExt":45,"email":74},"Joel Rodgers","205-515-3590","jrodgers@uabmc.edu",{"name":68,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":58,"countryCode":59,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Emory University \u002F Grady Memorial Hospital","RECRUITING","Atlanta","Georgia","30322",{"type":61,"coordinates":83},[84,85],-84.38798,33.749,{"lat":85,"lon":84},[88,92,96],{"name":89,"role":43,"phone":90,"phoneExt":45,"email":91},"Christopher Dente, MD","404-251-8915","cdente@emory.edu",{"name":93,"role":43,"phone":94,"phoneExt":45,"email":95},"Elizabeth Dee","404-251-8912","esitek@emory.edu",{"name":89,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":98,"status":54,"city":99,"state":100,"zip":101,"country":58,"countryCode":59,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Indiana University Health University Hospital","Indianapolis","Indiana","46202",{"type":61,"coordinates":103},[104,105],-86.15804,39.76838,{"lat":105,"lon":104},[108,112,116],{"name":109,"role":43,"phone":110,"phoneExt":45,"email":111},"Luke Lopas, MD","317-944-9400","llopas@iuhealth.org",{"name":113,"role":43,"phone":114,"phoneExt":45,"email":115},"Lauren Hill","314-496-0604","hillc@iu.edu",{"name":109,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":118,"status":78,"city":119,"state":120,"zip":121,"country":58,"countryCode":59,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Duke University Hospital","Durham","North Carolina","27705",{"type":61,"coordinates":123},[124,125],-78.89862,35.99403,{"lat":125,"lon":124},[128,132,136],{"name":129,"role":43,"phone":130,"phoneExt":45,"email":131},"Joseph F Moure, MD","919-681-8799","joseph.fernandezmoure@duke.edu",{"name":133,"role":43,"phone":134,"phoneExt":45,"email":135},"Allyn Damman","919-259-4414","allyn.meredith@duke.edu",{"name":129,"role":40,"phone":45,"phoneExt":45,"email":45},{"facility":138,"status":54,"city":139,"state":140,"zip":141,"country":58,"countryCode":59,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Brooke Army Medical Center","Fort Sam Houston","Texas","78234",{"type":61,"coordinates":143},[144,145],-98.4417,29.45303,{"lat":145,"lon":144},[148,152],{"name":149,"role":43,"phone":150,"phoneExt":45,"email":151},"Zachary Roward, MD","210-916-3400","zachary.t.roward.mil@health.mil",{"name":149,"role":40,"phone":45,"phoneExt":45,"email":45},{"type":154,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[156,158,160,162,164,166,167],{"name":157,"class":6},"Duke University",{"name":159,"class":6},"University of Alabama at Birmingham",{"name":138,"class":161},"FED",{"name":163,"class":6},"Grady Memorial Hospital",{"name":165,"class":6},"Indiana University Health",{"name":39,"class":161},{"name":168,"class":6},"Emory University","100586924","pilot-trial-for-woundx-clinical-decision-support-tool-100586924",false,"NCT06921707","Pilot Trial for WounDx™ Clinical Decision Support Tool","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","Inclusion Criteria:\n\n* Wound surface area ≥75cm 2\n* Extremity injury (including shoulder and buttock - without visceral communication)\n* Wound amenable to Negative Pressure Wound Therapy using 3M™ V.A.C. ® canisters without gel pack\n\nExclusion Criteria:\n\n* Insulin Dependent Diabetes\n* Peripheral Vascular Disease\n* Connective Tissue Disorders\n* Preexisting immunosuppressive conditions or immunosuppression therapy\n* Pregnancy\n* Prisoners","ALL","18 Years","65 Years",{"count":180,"type":181},40,"ESTIMATED","INTERVENTIONAL",[184],"NA","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.",[187,188,189,190,191,192,193],"Wounds","Wounds and Injuries","Extremity Injury","Traumatic Wounds and Injuries","Amputation, Traumatic\u002FSurgery","Amputation, Wound","Open Fracture Wounds",[187,189,23,195,196,197,198],"Delayed Wound Closure","Cytokine Biomarkers","Wound Effluent","Traumatic Extremity Wounds","2026-04-14",{"date":201,"type":202},"2026-04-17","ACTUAL",{"date":204,"type":181},"2026-03-21",{"date":206,"type":181},"2026-09-20",{"name":5,"class":6},5]