[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462602":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":46,"responsibleParty":66,"collaborators":69,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":32,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":32,"enrollmentInfo":81,"targetDuration":32,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":49,"whyStopped":32,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Charles University, Czech Republic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Topical sevoflurane","EXPERIMENTAL","The active treatment group will have sevoflurane applied at approximately 1 ml\u002Fcm2 at the start of wound treatment,",[13],"Drug: Sevoflurane",{"label":15,"type":16,"description":17,"interventionNames":18},"Cyteal","ACTIVE_COMPARATOR","the control group will only have a standard rinse solution with Cyteal PIERRE FABRE MEDICAMENT, France (100 ml of skin fluid contains hexamidine diisetione 100 mg, chlorohexidine digluconate (solutio 20 %) 100 mg and chlorocresol 300 mg), with sevoflurane used to soak the absorbent material held under the distal pole of the wound.",[19],"Combination Product: Cyteal",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sevoflurane","Topical application of 1 mL sevoflurane per 1 cm2 ulcer area once or two times daily.",[9],[27],"Sevorane",{"type":29,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"COMBINATION_PRODUCT","Rinsing and cleaning of ulcer.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Jiří Málek, M.D.","3rd Medical Faculty of Charles University","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Jiri Malek, M.D.","CONTACT","+4202671622461","malekj@fnkv.cz",{"name":40,"role":41,"phone":45,"phoneExt":32,"email":43},"+4202671622272461",[47],{"facility":48,"status":49,"city":50,"state":32,"zip":51,"country":52,"countryCode":32,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Faculty Hospital Kralovske Vinohrady","RECRUITING","Prague","100 00","Czechia",{"type":54,"coordinates":55},"Point",[56,57],14.42076,50.08804,{"lat":57,"lon":56},[60,61,64],{"name":40,"role":41,"phone":32,"phoneExt":32,"email":32},{"name":62,"role":63,"phone":32,"phoneExt":32,"email":32},"Spyridon Gkalpakiotis, M.D.","SUB_INVESTIGATOR",{"name":65,"role":63,"phone":32,"phoneExt":32,"email":32},"Alice Kurzova, M.D.",{"type":37,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Jiri Malek","Assoc. Prof. Jiri Malek, MD, Ph.D.",[70],{"name":48,"class":71},"OTHER_GOV","100462602","phase-4-topical-sevoflurane-for-treatment-of-chronic-leg-ulcers-100462602",false,"NCT05303805","Topical Sevoflurane for Treatment of Chronic Leg Ulcers","Analgesic and Healing Effect of Topical Sevoflurane for Chronic Venous Ulcers","Inclusion Criteria:\n\n* Patients with painful (pain intensity on the numerical scale NRS 0-10 is NRS\\>4) non- healing tibial venous ulcers\n\nExclusion Criteria:\n\n* Allergy to sevoflurane\n* Inability to understand the pain-intensity questionnaire","ALL","18 Years",{"count":82,"type":83},50,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","Patients with painful non-healing leg ulcer will be enrolled in the clinical single-blinded randomized study. The active treatment group will have sevoflurane applied at approximately 1 ml\u002Fcm2 at the start of wound treatment, the control group will only have a standard rinse solution with Cyteal TM (Pierre Fabre Medicament, France). Further treatment will then be carried out in the standard manner. The duration of the study will be 5 days; if the defect heals earlier, it will be terminated early.\n\nExclusion criteria: allergy to sevoflurane, inability to understand the questionnaire\n\nParameters to be monitored will be pain intensity, microbial colonization, appearance and size of the defect",[89],"Leg Ulcer",[89,23,91,92,93],"Pain","Healing ulcer","Microbial colonization","2024-08-24",{"date":96,"type":97},"2024-08-27","ACTUAL",{"date":99,"type":97},"2022-05-02",{"date":101,"type":83},"2027-01-31",{"name":5,"class":6},1]