[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100331368":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":40,"responsibleParty":72,"collaborators":75,"id":77,"slug":18,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":18,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":104,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hyperbaric oxygen therapy","EXPERIMENTAL","30 sessions of Hyperbaric oxygen therapy, 90min treatment at 2,4 ATA(atmosphere absolute) with 100% oxygen.First session must be given within 7 days after initial amputation. Treatment is given as outpatient treatment after discharge from hospital.",[13],"Procedure: Hyperbaric oxygen therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Control group will be given standard of care with follow up at the outpatient clinic after discharge from hospital.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"PROCEDURE","Breathing 100% oxygen for 30+30+30 min at 2,4 ATA. in a multiplace hyperbaric chamber. Total of 30 sessions",[9],[25],{"name":26,"affiliation":27,"role":28},"Jonas V Rydinge, MD","Ullevål University Hospital, orthopedic department","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Jonas Rydinge, MD","CONTACT","+4792291795","+47 92291795","jonryd@ous-hf.no",{"name":37,"role":32,"phone":38,"phoneExt":38,"email":39},"Elisabeth I Ellingsen Husebye, MD, PhD","+47 95133773","uxngng@ous-hf.no",[41,59],{"facility":42,"status":43,"city":44,"state":18,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Diakonhjemmet Hospital","RECRUITING","Oslo","0319","Norway",{"type":48,"coordinates":49},"Point",[50,51],10.74609,59.91273,{"lat":51,"lon":50},[54,58],{"name":55,"role":32,"phone":56,"phoneExt":18,"email":57},"Mads Sundet, MD","+4741661770","mads.sundet@icloud.com",{"name":55,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":60,"status":43,"city":44,"state":18,"zip":61,"country":46,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Orthopedic Center, Ullevål University Hopspital","0407",{"type":48,"coordinates":63},[50,51],{"lat":51,"lon":50},[66,69,71],{"name":67,"role":32,"phone":68,"phoneExt":18,"email":18},"Elisabeth Ellingsen Husebye, MD, PhD","+47 23027884",{"name":70,"role":32,"phone":34,"phoneExt":34,"email":35},"Jonas Rydinge",{"name":31,"role":28,"phone":18,"phoneExt":18,"email":18},{"type":28,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Elisabeth Ellingsen Husebye","Principal Investigator",[76],{"name":42,"class":6},"100331368",false,"NCT03594344","Additional Hyperbaric Oxygen After Lower Extremity Amputation","Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial","AHOLEA","Inclusion Criteria:\n\n* Lower extremity amputation because of chronic wound, osteomyelitis, ischemia, necrosis.\n* Fit to receive hyperbaric oxygen therapy determined by an anesthesiologist\u002FHyperbaric Medicine Physician.\n* Able to cooperate and follow up appointments\n* Included within 7 days after final surgery\n\nExclusion Criteria:\n\n* Not fulfilling inclusion criteria\n* Pregnancy\n* Dementia","ALL","18 Years","90 Years",{"count":88,"type":89},120,"ESTIMATED","INTERVENTIONAL",[92],"NA","This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or control group.",[95,96,97,98,99,100,101,102,103],"Diabetes Mellitus","Claudication, Intermittent","Critical Limb Ischemia","Osteomyelitis","Amputation","Lower Extremity Ulcer","Diabetic Angiopathy","Diabetic Neuropathies","Diabetic Foot",[105,106,107,9,108],"Diabetic foot","Diabetes","Lower extremity amputation","HBOT","2025-03-25",{"date":111,"type":112},"2025-03-30","ACTUAL",{"date":114,"type":112},"2018-07-04",{"date":116,"type":89},"2026-12-31",{"name":5,"class":6},2]