[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445008":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":60,"collaborators":18,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":18,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":18,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":18,"overallStatus":81,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Texas Woman's University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Smart insoles + Education","EXPERIMENTAL","Participants in this group will receive a 90-minute group session education on foot self-care strategies (daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch)",[13],"Behavioral: A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion",{"label":15,"type":16,"description":17,"interventionNames":18},"Smart Insoles","NO_INTERVENTION","Participants in this group will not receive a 90-minute group session education on foot self-care, but will receive foot care supplies, insoles and smart watch",null,{"label":20,"type":16,"description":21,"interventionNames":18},"Usual Care","Participants will not receive foot self-care education or the use of insoles and smart watch.",[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":18},"BEHAVIORAL","A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion","A 90-minute group session to educate patients on foot self-care strategies (daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch). Follow-up Care: A biweekly 30-minute one-on-one follow-up phone discussion (i.e., daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch, addressing feedback and questions regarding the intervention and prevention of foot-related complications).",[9],[29],{"name":30,"affiliation":5,"role":31},"Ngozi Mbue","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Ngozi Mbue, PhD","CONTACT","7137942892","nmbue@twu.edu",{"name":39,"role":35,"phone":40,"phoneExt":18,"email":41},"Bijan Najafi, PhD","7137981158","bijan.najafi@bcm.edu",[43,56],{"facility":44,"status":18,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":18},"Baylor College of Medicine","Houston","Texas","77030","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-95.36327,29.76328,{"lat":54,"lon":53},{"facility":5,"status":18,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":57,"geoPoint":59,"contacts":18},{"type":51,"coordinates":58},[53,54],{"lat":54,"lon":53},{"type":61,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100445008","benefits-of-insoles-with-real-time-alert-and-foot-self-care-education-100445008",false,"NCT05074849","Benefits of Insoles With Real-Time Alert and Foot Self-Care Education","Benefits of Insoles With Real-Time Alert and Foot Self-Care Education in Improving Adherence for Prescribed Footwear in Patients With Diabetes Mellitus","Inclusion Criteria:\n\n* Men or women 18 years old or older,\n* Diagnosis of Diabetes Mellitus,\n* Ambulatory, Uses prescribed diabetes footwear.\n* Those willing and able to attend follow up visits such as long distance (i.e. greater than 30 miles to recruitment sites).\n* Those able to read or follow directions.\n\nExclusion Criteria:\n\n* Active Charcot Arthropathy or major foot deformity,\n* Cardiopulmonary disease (e.g. recent MI, Stroke),\n* Gangrene, active infection. Montreal Cognitive Assessment (MOCA\\\u003C20).\n* Wide spread malignancy or systemically immunocompromising disease.",true,"ALL","18 Years",{"count":73,"type":74},72,"ESTIMATED","INTERVENTIONAL",[77],"NA","Novel approaches to promote adherence to diabetic footwear and prevent high incidence of diabetes foot ulcers are urgently needed. Investigators propose to translate an innovative and practical technology to supplement clinical and risk evaluation for patients with diabetes through wearable insoles and smart watch, along with foot self-care education, to improve adherence to prescribed footwear and reduce incidence of foot ulcers in those with diabetes and at risk for foot ulcers.",[80],"Diabetes Complications","NOT_YET_RECRUITING","2025-04-11",{"date":84,"type":85},"2025-04-16","ACTUAL",{"date":87,"type":74},"2026-10-20",{"date":89,"type":74},"2026-12-30",{"name":5,"class":6},2]