[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100359894":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":64,"collaborators":24,"id":67,"slug":24,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":24,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Missouri-Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hindfoot Offloading Braces \u002F Immediate Weight-bearing","EXPERIMENTAL","Diabetic patients over 18 years of age who sustained an isolated (non-pilon) ankle fracture will undergo ORIF of the ankle fracture within 3 weeks of the event",[13],"Other: Postoperative protocol (Immediate weight bearing)",{"label":15,"type":16,"description":11,"interventionNames":17},"No Hindfoot Offloading Braces \u002F Delayed Weight-Bearing","PLACEBO_COMPARATOR",[18],"Other: Postoperative Protocol (Delayed Weight Bearing)",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Postoperative protocol (Immediate weight bearing)","After ORIF of the ankle fracture, the patient will be randomized to follow an immediate weight bearing rehabilitation protocol using an offloading hindfoot brace",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Postoperative Protocol (Delayed Weight Bearing)","After ORIF of the ankle fracture, the patient will be randomized to follow a standard delayed weight-bearing rehabilitation protocol",[15],[30],{"name":31,"affiliation":32,"role":33},"Kyle M Schweser, MD","Assistant Professor Orthopaedic Trauma\u002FFoot and Ankle","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Vicki L Jones, MEd","CONTACT","573-882-7583","jonesvicki@umsystem.edu",{"name":41,"role":37,"phone":42,"phoneExt":24,"email":43},"Ennio Rizzo Esposito, MD","3468126445","eardvb@health.missouri.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of Missouri Health System","RECRUITING","Columbia","Missouri","65212","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-92.33407,38.95171,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":62,"phoneExt":24,"email":63},"Stacee Clawson, BSN, RN","573-884-9017","clawsons@health.missouri.edu",{"type":65,"investigatorFullName":66,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Kyle Schweser MD","100359894",false,"NCT03966027","Immediate Vs. Delayed Weight Bearing Postoperative Protocol in Diabetic Ankle Fractures","Diabetic Ankle","Inclusion Criteria:\n\n1. Adults 18 and ove\n2. Positive for diabetes\n3. Positive monofilament test\n4. Isolated ankle fracture (non-pilon) and undergoing operative intervention within 3 weeks of fracture\n5. Weight less than 275 (124kg)\n6. Can tolerate and comply with brace\n7. No signs of pre-existing charcot arthroplasty or ankle deformity\n\nExclusion Criteria:\n\n1. Children\n2. Pregnant patients\n3. No signs of diabetes complicated by neuropathy\n4. Non-operative ankle fractures\n5. Multiple extremity injury\n6. Cannot follow post-operative protocol\n7. Chronic ankle fractures receiving surgery beyond 3 weeks of injury","ALL","18 Years",{"count":76,"type":77},25,"ESTIMATED","INTERVENTIONAL",[80],"NA","Operatively managed diabetic ankle fractures have significant risk for complications. The cause for failure is likely multifactorial, however, a component of failure has to do with an inability to process pain and pressure normally. This loss of protective sensation allows for an increase in abnormal stresses placed on the recently repaired fractures. Historically, diabetics have been kept non weight bearing for extended periods of time, which has its own functional and cardiovascular issues. The purpose of the study is to determine if a protocol of immediate weight bearing with a hindfoot offloading brace after surgically corrected ankle fracture in a diabetic patient will maintain adequate motion, have no difference in complications when compared to regular non-immediate weight bearing protocols, and lead to good outcome scores and patient satisfaction scores",[83],"Ankle Fractures",[85],"Diabetic Ankle Fractures","2025-08-22",{"date":88,"type":89},"2025-08-24","ACTUAL",{"date":91,"type":89},"2020-08-01",{"date":93,"type":77},"2026-06-15",{"name":66,"class":6},1]