[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521182":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":67,"collaborators":10,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":10,"studyType":83,"phases":10,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"IRCCS Policlinico S. Donato","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"1) Critical limb ischemia (CLI);",null,"1)Critical limb ischemia (CLI):\n\n* Patients suffering from CLI undergoing lower limb revascularization via subgenual femoropopliteal bypass. muscle biopsies willbe taken.\n* Patients suffering from terminal CLI and\u002For gangrene of the lower limb undergoing thigh amputation. Muscle biopsies will be taken.\n* Patients suffering from terminal CLI and\u002For gangrene of the lower limb undergoing leg amputation. Muscle biopsies will be taken.",[13],"Diagnostic Test: Critical limb ischemia: analysis of RNAs",{"label":15,"type":10,"description":16,"interventionNames":17},"2)Controls","2)Controls: patients affected by infrarenal abdominal aortic aneurysm (AAA) free from CLI, affected and not affected by type 2 diabetes mellitus, undergoing endovascular exclusion surgery of the AAA (EVAR), similar by age and sex to CLI patients. Sartorius muscle biopsies will be taken.",[18],"Diagnostic Test: Controls: analysis of RNAs",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DIAGNOSTIC_TEST","Critical limb ischemia: analysis of RNAs","analysis of miRNA expression levels",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Controls: analysis of RNAs","analysis of miRNAs expression levels",[15],[30],{"name":31,"affiliation":5,"role":32},"Fabio Martelli","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Fabio Dr Martelli","CONTACT","+39 0226437762","fabio.martelli@grupposandonato.it",{"name":40,"role":36,"phone":41,"phoneExt":10,"email":42},"Giovanni Dr Nano, MD","+39 0252771","giovanni.nano@grupposandonato.it",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Irccs Policlinico San Donato","RECRUITING","San Donato Milanese","Milan","20097","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],9.26838,45.41047,{"lat":56,"lon":55},[59,62,65],{"name":60,"role":36,"phone":61,"phoneExt":10,"email":38},"FABIO MARTELLI, PhD","0252774683",{"name":63,"role":64,"phone":10,"phoneExt":10,"email":10},"Giovanni Nano, MD","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":10,"phoneExt":10,"email":10},"Paolo Righini, MD",{"type":32,"investigatorFullName":31,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Dr.","100521182","mirnas-in-critical-limb-ischemia-mirnacli-100521182",false,"NCT06066268","miRNAs in Critical Limb Ischemia (miRNACLI)","Role of microRNAs in Critical Limb Ischemia","miRNACLI","Inclusion Criteria:\n\nCases:\n\n* patients affected by CLI candidates for popliteal exploration surgery and\u002For subgenual femoropopliteal bypass.\n* Patients affected by CLI with irreversible ischemia and\u002For distal gangrene of the lower limb candidates for major amputation of the lower limb.\n\nControls:\n\n• patients affected by infrarenal abdominal aortic aneurysm (AAA) undergoing endovascular exclusion surgery of the AAA (EVAR) who are free from CLI, affected and not affected by type 2 diabetes mellitus.\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients carriers of genetic diseases\n* Patients suffering from malignant neoplasia","ALL","40 Years","85 Years",{"count":81,"type":82},80,"ESTIMATED","OBSERVATIONAL","For the present study, 40 patients affected by critical limb ischemia of different severity will be enrolled: patients affected by critical limb ischemia undergoing subgenual femoropopliteal bypass; patients suffering from terminal ischemia causing gangrene and therefore undergoing major amputation of the lower limb. Biopsies from the first 20 enrolled patients will be used for miRNA profiling. The total of 40 biopsies obtained from all enrolled patients will instead be used for the validation of the miRNAs identified in the profiling.\n\nThe results obtained will be compared with those obtained in 40 control patients affected by infrarenal abdominal aortic aneurysm (AAA) undergoing endovascular exclusion surgery (EVAR) of the AAA without any ischemia of the lower limbs. Also in this case the biopsies of the first 20 control patients enrolled will be used for miRNA profiling. The total of 40 biopsies obtained from all control patients will instead be used for the validation of the miRNAs identified in the profiling. A total of 80 patients (40 cases and 40 controls) will be enrolled.",[86],"Critical Limb Ischemia",[88,89],"microRNA","Ischemia","2025-04-29",{"date":92,"type":93},"2025-04-30","ACTUAL",{"date":95,"type":93},"2016-05-31",{"date":97,"type":82},"2026-05-31",{"name":5,"class":6},1]