[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456803":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":18,"locations":29,"responsibleParty":51,"collaborators":18,"id":54,"slug":18,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":18,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":18,"enrollmentInfo":62,"targetDuration":18,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":18,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Flexor tenotomy",[13],"Procedure: Flexor tenotomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Controle","NO_INTERVENTION","Usual-care",null,[20],{"type":21,"name":11,"description":22,"armGroupLabels":23,"otherNames":18},"PROCEDURE","Minimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon",[9],[25],{"name":26,"affiliation":27,"role":28},"Gino M.M.J. Kerkhoffs, MD, PhD","Amsterdam UMC, location VUmc","PRINCIPAL_INVESTIGATOR",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Amsterdam UMC - location MAMC","RECRUITING","Amsterdam","North Holland","1105AZ","Netherlands",{"type":38,"coordinates":39},"Point",[40,41],4.88969,52.37403,{"lat":41,"lon":40},[44,49],{"name":45,"role":46,"phone":47,"phoneExt":18,"email":48},"Mens","CONTACT","+ 31 020 56 66495","marieke.mens@amsterdamumc.nl",{"name":50,"role":28,"phone":18,"phoneExt":18,"email":18},"Gino M.M.J. Kerkhoffs, Professor",{"type":28,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Marieke Mens","Coördinating investigator","100456803",false,"NCT05228340","Flexor Tenotomy and Ulcer Recurrence","The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial","Inclusion Criteria:\n\n* A minimum age of 18 years\n* Sufficient understanding of Dutch\u002FEnglish language\n* Capable of filling out informed consent\n* Peripheral polyneuropathy\n* Diabetes mellitus type 1 or 2\n* A minimum of one claw\u002Fhammer toe\n* A documented history of diabetic ulcers underneath the toe apex in the past 5 years\n\nExclusion Criteria:\n\n* No written informed consent\n* Not meeting the inclusion criteria\n* Open ulcers on the toes\n* Previous participation in the study\n* Pregnant women\n* Concomitant participation in a study in which the patient is exposed to X-rays","ALL","18 Years",{"count":63,"type":64},66,"ESTIMATED","INTERVENTIONAL",[67],"NA","The main purpose of this study is to assess the efficacy of flexor tenotomy on the prevention of recurrence of toe ulcers in people with diabetes and a history of toe ulceration. Additionally, the investigators aim to assess interphalangeal joints (IPJ) and metatarsophalangeal joint (MTPJ) angles in a weight-bearing and non-weight-bearing position, bare-foot plantar pressure during walking and quality of life before and after the intervention and compare between study groups.",[70,71],"Hammer Toe Syndrome","Foot Ulcer, Diabetic","2022-03-15",{"date":74,"type":75},"2022-03-29","ACTUAL",{"date":72,"type":75},{"date":78,"type":64},"2027-02",{"name":5,"class":6},1]