[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598548":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":26,"responsibleParty":42,"collaborators":26,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":26,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":26,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":26},{"fullName":5,"class":6},"University of Arizona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IV and\u002For oral antibiotics with local antibiotic loaded calcium sulfate beads","EXPERIMENTAL","These will be patient who will receive active systemic antibiotics plus calcium sulfate beads loaded with antibiotics",[13],"Device: Calcium sulfate beads (sham beads)",{"label":15,"type":16,"description":17,"interventionNames":18},"IV and\u002For oral antibiotics plus calcium sulfate beads without antibiotics (sham beads)","ACTIVE_COMPARATOR","These patients will receive IV and\u002For oral antibiotics plus sham beads. They will receive antibiotics systemically.",[19],"Drug: Antibiotic loaded calcium sulfate beads",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Antibiotic loaded calcium sulfate beads","Calcium sulfate beads will be loaded with best available antibiotics based on surgeon\u002Finfectious disease specialist determination from the following options (vancomycin, daptomycin, cefazolin, cefepime, tobramycin, amphotericin B, micafungin, and voriconazole).",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DEVICE","Calcium sulfate beads (sham beads)","Calcium sulfate beads will be prepared without added antibiotics and placed during the second surgery.",[9],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Talha Riaz, MD","CONTACT","+1 520 626 8569","riazt@arizona.edu",{"name":39,"role":35,"phone":40,"phoneExt":26,"email":41},"Jose Elizondo","+15206210316","joselizondo5@arizona.edu",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Talha Riaz","MD","100598548","phase-4-antibiotic-impregnated-beads-in-osteomyelitis-100598548",false,"NCT07072923","Antibiotic Impregnated Beads in Osteomyelitis","Utility of Antibiotic Impregnated Beads in Lower Extremity Osteomyelitis","Inclusion Criteria:\n\n* patients with lower extremity osteoarticular infections with or without hardware\n\nExclusion Criteria:\n\n* patients who are hemodynamically unstable or have altered mental status and cannot give consent\n* patient per investigators discretion are excluded","ALL","18 Years",{"count":56,"type":57},100,"ESTIMATED","INTERVENTIONAL",[60],"PHASE4","Lower extremity bone infections, such as osteomyelitis, often occur after bone fractures, surgery, or when prosthetic joints or hardware become infected. Treatment usually includes antibiotics, chosen based on the infection's specifics. Options include intravenous (IV) or oral antibiotics, and sometimes local treatment with antibiotic-loaded beads placed directly at the infection site. Traditionally, these beads are made of non-absorbable materials, requiring a second surgery to remove them. However, a newer approach uses absorbable calcium sulfate beads, which can deliver higher antibiotic doses and don't need removal. This study will compare the use of IV and\u002For antibiotics in combination with absorbable antibiotic calcium sulfate beads with IV and\u002For oral antibiotics without absorbable beads, which serves as the current standard of care.",[63,64,65],"Osteomyelitis of the Foot","Antibiotic Impregnated Beads","Osteomyelitis of Lower Extremities",[67],"osteomyelitis, lower extremity, foot, calcium sulfate beads","NOT_YET_RECRUITING","2025-07-09",{"date":71,"type":72},"2025-07-18","ACTUAL",{"date":74,"type":57},"2025-09-01",{"date":76,"type":57},"2027-09-30",{"name":5,"class":6}]