[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04887688":3,"trial-entities:NCT04887688":96,"trial-summary:NCT04887688":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":49,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":64,"locations":67,"central_contacts":87,"overall_officials":92,"references":94,"see_also_links":95},"NCT04887688","F2166-R","Exciflex Electroceutical Banadage for Chronic Wound Therapy","Toward Smart Personalized Electrotherapy for Enhanced Healing of Chronic Wounds","RECRUITING","2029-09-30","2026-08","2026-08-10","2022-10-05","VA Office of Research and Development","FED",false,"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 Louis Stokes Cleveland VA Medical Center (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.","The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of the exciflex bandage in clinical use. Non-invasive assessments will include multi-modal imaging using the Mimosa Pro imaging system, MolecuLight and wound swabs to collect wound bed fluid thus meeting the recommendations of Ramsay et al. for obtaining accurate, reliable standardized samples. Wound healing primary endpoints will follow Wound Care Collaborative Community guidance. The study cohort will comprise Veterans with chronic wounds.\n\nA parallel-group randomization will be used and participants will be randomly assigned to one of two groups: the experimental or investigation group (Group A) or the control group (Group B). Random allocation software will be used to produce qualified lists for parallel group assignment a priori and ensure that participants are randomized into groups that result in equal sample sizes Each will have a 50% chance of being assigned to either group. The two groups are Group A (exciflex treatment and monitoring) or Group B (sham treatment, i.e. exciflex monitoring without treatment activated)",[19,20,21,22],"Chronic Wound","Diabetes","Spinal Cord Injury","Ischemic Wound",[],"INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},16,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","exciflex","untethered electronic bandage with all the components of a surface stimulation system mounted on a flexible substrate.",[37],"Group A: Wound treated using exciflex",[39,43,46],{"measure":40,"description":41,"timeFrame":42},"Digital imaging","Quantify wound size (mm2 for surface area, mmm3 for volume). The outcomes measures of wound surface area \\& wound volume are done by the investigators' 3D wound imaging camera that produces a digital output which includes both wound surface area (SA) \\& wound volume. One is derived from the other, i.e. Wound volume = SA x average depth.","At each bandage change for up to 6 weeks",{"measure":44,"description":45,"timeFrame":42},"IR imaging","Wound bed temperature (degrees C)",{"measure":47,"description":48,"timeFrame":42},"Laser Speckle imaging","Wound region blood flow (blood perfusion using arbitrary units)",[50],{"measure":51,"description":52,"timeFrame":53},"Wound swabs","Further analysis using real-time polymerase chain reaction (PCR) for assessment of wound infection and healing biomarkers, including but not limited to VEGF and TNF-alpha. rt-PCR is a single assessment process to measure multiple biomarkers of wound infection and healing from a single sample, using plates that contain up to 96 different biomarkers each.","At every bandage change for up to 6 weeks","ALL","18 Years",null,{"inclusion":58,"exclusion":62,"raw_text":63},[59,60,61],"All participants with chronic wounds treated at LSCVAMC 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","Pregnancy",[],"Inclusion Criteria:\n\n* All participants with chronic 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* Pregnancy",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":84},"Louis Stokes VA Medical Center, Cleveland, OH","Cleveland","Ohio","44106-1702","United States",[75,81],{"name":76,"role":77,"phone":78,"phoneExt":79,"email":80},"Katie R Schwartz, RN","CONTACT","(216) 791-3800","63802","Katelyn.Schwartz@va.gov",{"name":82,"role":83},"Kath M. Bogie, PhD","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},41.4995,-81.69541,[88],{"name":89,"role":77,"phone":90,"email":91},"Kath M Bogie, PhD","(204) 778-3083","Katherine.Bogie@va.gov",[93],{"name":82,"affiliation":69,"role":83},[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[98,22,21],"Diabetes Mellitus",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is a randomized study with two groups, involving 16 participants. You would have a 50% chance of receiving the exciflex bandage or standard care.","completed","Exciflex for Chronic Wound Therapy","This study is testing a new electronic bandage called exciflex for people with chronic wounds, especially those caused by poor blood flow (ischemic wounds). It aims to see if exciflex works better than standard care to help wounds heal. You might be eligible if you are a Veteran with a chronic ischemic wound, particularly if you have a spinal cord injury or diabetes and are receiving wound care. Researchers will measure wound size using special imaging techniques at each bandage change for up to six weeks to see how well the treatment is working. The study is currently unclear on its recruitment status.","Your wound healing will be monitored for up to six weeks.",103,"Your wound will be digitally imaged, and infrared and laser speckle imaging will be performed at each bandage change for up to six weeks.","Not stated in the trial record.",[34],"v2"]