[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626910":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":18,"responsibleParty":38,"collaborators":18,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":18,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":63,"whyStopped":18,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":18},{"fullName":5,"class":6},"University of Huddersfield","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Arm","EXPERIMENTAL","The study group will be given a toe divider",[13],"Device: Otoform toe divider",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","NO_INTERVENTION","Participants will continue to receive regular treatment.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Otoform toe divider","Otoform is a moldable silicone used to make a toe divider.",[9],[26],{"name":27,"affiliation":28,"role":29},"John Stephenson","Huddersfield University","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Abigail R Dagg","CONTACT","07904456874","abigail.dagg@hud.ac.uk",{"name":32,"role":33,"phone":34,"phoneExt":18,"email":37},"abigail.dagg@nhs.net",{"type":39,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100626910","toe-study-treatment-and-gait-analysis-following-an-excised-lesser-toe-100626910",false,"NCT07441772","TOE Study: Treatment and Gait Analysis fOllowing an Excised Lesser Toe","A Feasibility Randomised Controlled Study to Examine the Effect of Otoform Toe Dividers in the Treatment of Patients With Diabetes Mellitus Following a Lesser Toe Amputation","TOE","Inclusion Criteria:\n\n1. Participants over the age of 18.\n2. Participants with DM and a lesser toe amputation.\n3. Participants who wish to take part and provide informed written consent\n4. Participants who are mobile (including those who use walking aids).\n\nExclusion Criteria\n\n1. Participants under the age of 18.\n2. Participants who do not have DM.\n3. Participants who have active ulcerations or surgical sites.\n4. Participants who had had a 1st toe and\u002For ray amputation.\n5. Participants with neuroarthropathy or other marked foot deformities.\n6. Participants who already wear a toe divider.\n7. Participants who have a known allergy to the silicone or catalyst being used.\n8. Participants who are immobile.","ALL","18 Years","105 Years",{"count":52,"type":53},30,"ESTIMATED","INTERVENTIONAL",[56],"NA","Summary of study\n\nThe study will examine patients with Diabetes Mellitus (DM) who have had a lesser toe amputations (LTA) (toes 2nd3rd,4th or 5th). It is currently not understood how this affects the way patients walk and foot function. No previous studies have been undertaken to examine this and its potential for causing further ulceration risk.\n\nThis study is a feasibility study. It is designed to see if it is possible to undertake a large, randomised trial. It will explore how participants are recruited, kept in the study and how easy it is to follow the study protocol.\n\nAim of the study\n\nEstablish the feasibility of a corresponding full scale investigation into to the effectiveness of a toe divider made from Otoform for patients with DM following an LTA.\n\nStudy Design\n\n1. Participants will be recruited from Mid Yorkshire NHS teaching Hospital.\n2. Participants will be randomised to receive either standard care or an otoform toe divider.\n3. Participants age, gender, medical history, medication and blood sugar levels will be recorded.\n4. Vascular and neurological assessments, foot posture and toe deformities will be undertaken and recorded.\n5. All participants will have pressures measured on the plantar aspects of both feet.\n6. Follow up visits will be arranged every 6 weeks for12 months for all participants to monitor foot health and changes in walking pattern and pressure redistribution.\n7. If an ulceration or other foot complication occurs, the participants will be removed from the study and appropriate treatment given (the rescue arm of the study).",[59,60],"Diabetes Mellitus","Amputation",[62],"Diabetes Mellitus, Lesser Toe Amputation","NOT_YET_RECRUITING","2026-02-27",{"date":66,"type":67},"2026-03-02","ACTUAL",{"date":69,"type":53},"2026-04-01",{"date":71,"type":53},"2028-07-31",{"name":5,"class":6}]