[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471697":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":62,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":25,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":25,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Fisher and Paykel Healthcare","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Series","ACTIVE_COMPARATOR","Standard wound care for 4 weeks followed by intervention device wound care for up to 12 weeks.",[13],"Device: Series Topical Oxygen Therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Paired","Intervention device wound care to a portion of wound and standard wound care to the remaining portion of the wound, for up to 12 weeks.",[18],"Device: Paired Topical Oxygen Therapy",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Series Topical Oxygen Therapy","Standard care provided to the whole wound followed by intervention device care to the whole wound.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Paired Topical Oxygen Therapy","Care provided to one portion of wound by intervention device and standard care to remaining portion of wound.",[15],[31],{"name":32,"affiliation":33,"role":34},"Jolanta Krysa","Southern DHB Vascular Surgery","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Geoff Bold","CONTACT","+64 (09) 574 0100","geoff.bold@fphcare.co.nz",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Otago Vascular Diagnostics","RECRUITING","Dunedin","Otago","9016","New Zealand","NZ",{"type":51,"coordinates":52},"Point",[53,54],170.50361,-45.87416,{"lat":54,"lon":53},[57,60],{"name":58,"role":38,"phone":59,"phoneExt":25,"email":25},"Clinical Director","+64 3 474 0999",{"name":61,"role":38,"phone":59,"phoneExt":25,"email":25},"Clinical Nurse Specialist",{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100471697","oxygen-wound-therapy-feasibility-study-100471697",false,"NCT05422248","Oxygen Wound Therapy Feasibility Study","Inclusion Criteria:\n\n* Patients with hard to heal lower leg wounds as determined by the treating clinician.\n* Patient has a wound area greater than the area of the interface\n* Aged 16 years and over\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Lower limb wounds with bone or tendon exposed\n* Infected wounds which require treatment with antibiotics\n* Wounds with critical bioburden requiring a medicated dressing\n* Wounds that require dressing changes more than every second day, for example high exudating wounds\n* Wounds with slough covering more than 30% of the wound surface","ALL","16 Years",{"count":73,"type":74},10,"ESTIMATED","INTERVENTIONAL",[77],"NA","Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.",[80],"Chronic Leg Ulcer","2023-09-11",{"date":83,"type":84},"2023-09-13","ACTUAL",{"date":86,"type":84},"2022-12-01",{"date":88,"type":74},"2026-08-01",{"name":5,"class":6},1]