[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575466":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":26,"locations":35,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":83,"whyStopped":18,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Nova Scotia Health Authority","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bauerfeind Ankle Compression Sleeve","EXPERIMENTAL","Patients in this arm will be fitted for a Bauerfeind ankle compression sleeve at 6 weeks post-injury\u002Fpost-operative following the removal of their walking boot. Patients will use the compression sleeve until 6 months post-injury\u002Fpost-operative.",[13],"Other: Compression sleeve",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Patients in the control group will wear a walking boot until 6 weeks post-injury\u002Fpost-operative. Upon removal of the boot, no swelling aid will be provided to patients (as per standard of care)",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Compression sleeve","The Bauerfeind compression sleeve is a fabric sleeve designed to support the ankle during movement. It's made of a compressive knit material that increases sensorimotor feedback, enhances blood circulation, and stimulates metabolism. The design helps reduce ligament strain, activates the foot's stabilizing muscles more quickly, and improves joint coordination.",[9],[25],"Bauerfeind ankle compression sleeve",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":18,"email":31},"Devan Pancura, MSc","CONTACT","(902)473-7137","Devan.Pancura@nshealth.ca",{"name":33,"role":29,"phone":30,"phoneExt":18,"email":34},"Mark Glazebrook, PhD, MD","markglazebr@hotmail.com",[36],{"facility":37,"status":18,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Queen Elizabeth II Health Science Center","Halifax","Nova Scotia","B3H 3A7","Canada","CA",{"type":44,"coordinates":45},"Point",[46,47],-63.57688,44.64269,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":30,"phoneExt":18,"email":31},"Devan Pancura",{"type":53,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[55],{"name":56,"class":57},"Bauerfeind","UNKNOWN","100575466","phase-4-compression-therapy-for-swelling-management-following-ankle-injury-100575466",false,"NCT06772649","Compression Therapy for Swelling Management Following Ankle Injury","Investigating the Safety and Efficacy of Compression Therapy for Controlling Swelling in Post-Injury Ankle Management","Inclusion Criteria:\n\n* Patients undergoing outpatient ankle, mid-foot or hindfoot arthrodesis, fracture surgery, or non-operative ankle fracture management at the Queen Elizabeth II Health Sciences Center.\n* Aged 18 or over\n\nExclusion Criteria:\n\n* Patients undergoing other ankle procedures\n* Patients who have any signs of wound healing complications post-surgery\n* Patients who are unable to progress to walking boot and weight-bearing management at 6 weeks post operation\u002Finjury.\n* Patients with other co-morbidities that may create bias within the results (lymphedema, heart conditions etc.)\n* Patients who are unable to speak and read English, and\u002For in the opinion of the Principal Investigator are unable to provide fully informed consent.","ALL","18 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","After an injury or undergoing foot\u002Fankle surgery, patients often experience swelling in the injured area. Under current standard of care, plaster casts are removed at six weeks and patients are put in a walking boot. At this point in time of their recovery, patients are permitted to weight bear and move in their walking boot without other help, like crutches. This has shown to cause a significant amount of swelling in the ankle and foot between week six and twenty-six post-injury\u002Fsurgery.\n\nThere is not much research that has looked at the effects of compression on reducing swelling in post-operative and non-operative ankle fracture, mid-foot, hindfoot, or ankle arthrodesis. This research is important because post-injury swelling can lead to wound complications and limit functionality. Therefore, finding new ways to reduce swelling could help prevent future complications.\n\nThe purpose of this study is to see if the Bauerfeind ankle compression sleeve is a safe post-operative\u002Finjury foot and ankle swelling management tool. Use of a compression sleeve will be compared to just using a walking boot, which is current standard of care, to determine if the compression sleeve reduces post-operative\u002Finjury foot and ankle swelling.\n\nThe study will follow patients improvement in swelling and pain. The compression sleeve will also be assessed for product safety. Safety is determined by watching the frequency, severity and seriousness of any side effects or complications, known as adverse events, that may be experienced while in the study.\n\nThe Bauerfeind ankle compression sleeve has been and is currently used in humans as a swelling reducing devise in the foot and ankle but has not been studied in a randomized control trial.",[75,76],"Ankle Fracture","Ankle Arthrodesis",[78,79,80,81,82],"non-operative ankle fracture management","operative ankle fracture management","ankle arthrodesis","mid-foot arthrodesis","hind-foot arthrodesis","NOT_YET_RECRUITING","2025-01-22",{"date":86,"type":87},"2025-01-24","ACTUAL",{"date":89,"type":69},"2025-04-01",{"date":91,"type":69},"2026-05-30",{"name":5,"class":6},1]