[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430638":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":57,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":18,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":18,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Wound treated using exciflex","EXPERIMENTAL","Intervention treated wounds in Group A participants will be covered using the exciflex bandage which will be activated to deliver ES using a 10% duty cycle, i.e. ES will be active for 1 minute out of every 10 minutes. ES will be delivered for up to 10 weeks or until the wound is healed for 3 days. The exciflex bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically a 3D digital image and wound swabs will be obtained. The exciflex power\u002Fcontrol module will then be transferred to a new sterile flexible substrate and the exciflex bandage reapplied to the wound.",[13],"Device: exciflex",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B: Wound treated using standard of care","NO_INTERVENTION","Control treated wounds in Group B participants will be covered with a standard of care hydrogel dressing such as Restore (Hollister Inc) together with Tegaderm . The SoC dressing will be used for up to 10 weeks or until the wound is healed for 3 days. The SoC bandage will be changed when indicated clinically or every 5 days, whichever is sooner. At each bandage change, wound status monitored as described above, specifically a 3D digital image and wound swabs will be obtained. A fresh sterile SoC bandage will then be reapplied to the wound.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","exciflex","untethered electronic bandage with all the components of a surface stimulation system mounted on a flexible substrate.",[9],[26],{"name":27,"affiliation":28,"role":29},"Kath M. Bogie, PhD","Louis Stokes VA Medical Center, Cleveland, OH","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Kath M Bogie, PhD","CONTACT","(204) 778-3083","Katherine.Bogie@va.gov",[37],{"facility":28,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Cleveland","Ohio","44106-1702","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-81.69541,41.4995,{"lat":48,"lon":47},[51,56],{"name":52,"role":33,"phone":53,"phoneExt":54,"email":55},"Katie R Schwartz, RN","216-791-3800","63802","Katelyn.Schwartz@va.gov",{"name":27,"role":29,"phone":18,"phoneExt":18,"email":18},{"type":58,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100430638","exciflex-for-chronic-wound-therapy-100430638",false,"NCT04887688","Exciflex for Chronic Wound Therapy","Toward Smart Personalized Electrotherapy for Enhanced Healing of Ischemic Wounds","Inclusion Criteria:\n\n* All participants with chronic ischemic wounds treated at LSCVAMC will be potentially eligible for the study\n* Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long-Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care\n\nExclusion Criteria:\n\nIn addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include:\n\n* Age less than 18 years.\n* Pregnancy","ALL","18 Years",{"count":69,"type":70},16,"ESTIMATED","INTERVENTIONAL",[73],"NA","Objectives: The study objective is to carry a pilot clinical assessment comparing the exciflex bandage to standard of care (SoC) for ischemic wounds and will involve participants who are Veterans with lower extremity ischemic wounds.\n\nResearch Plan: The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use.\n\nMethodology: All participants with chronic ischemic wounds treated at LSCDVAMC will be potentially eligible for the study. Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care. In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include; (1)Age less than 18 years and (2)Pregnancy.\n\nClinical Significance: Chronic ischemic wounds fail to heal normally and are a major challenge in the long-term care of many Veterans. The exciflex bandage can improve outcomes and lower cost by automatically delivering electrotherapy without disturbing the wound dressing for up to seven days, unless indicated. The overall study goal is to complete pre-market testing and evaluation of the exciflex bandage system.",[76,77,78,79],"Chronic Wound","Diabetes","Spinal Cord Injury","Ischemic Wound","2025-09-04",{"date":82,"type":83},"2025-09-11","ACTUAL",{"date":85,"type":83},"2022-10-05",{"date":87,"type":70},"2029-09-30",{"name":5,"class":6},1]