[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560162":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":58,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Total Contact Cast (TCC) Comparator Arm","ACTIVE_COMPARATOR","standardised non-walking, non-removable, knee high, fibre-glass total contact cast",[13],"Device: Total Contact Cast",{"label":15,"type":10,"description":16,"interventionNames":17},"Posterior Slab Comparator Arm","posterior non-removable knee high slab",[18],"Device: Posterior Slab",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Total Contact Cast","Knee High Fiber Glass Total contact Cast",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Posterior Slab","Posterior Slab Knee high non walking",[15],[31],{"name":32,"affiliation":33,"role":34},"Ashu Rastogi, DM MD","PGIMER, India","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","9781001046","rastogi.ashu@pgi.ac.in",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Department of Endocrinology, PGIMER","RECRUITING","Chandigarh","160012","India","IN",{"type":49,"coordinates":50},"Point",[51,52],76.7884,30.73629,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":38,"phoneExt":25,"email":57},"Ashu Rastogi, DM","rastogi.ashu@pgimer.ac.in",{"type":34,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Ashu Rastogi","Associate Professor","100560162","contact-cast-versus-posterior-slab-as-offloading-modality-for-charcot-neuroarthropathy-100560162",false,"NCT06573554","Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy","Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy of Foot in Diabetes (OFFLOAD Study): A Multicentric, Non-inferiority Study","Inclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n* Unilateral pedal swelling\n* Active Charcot Neuroarthropathy\n* Age: 18 years and above.\n* Ability to Provide Consent\n\nExclusion Criteria:\n\n* presence of pedal ulcer,\n* osteoporosis (T score \\\u003C-2.5 at lumbar spine or hip),\n* gout,\n* active peptic ulcer disease,\n* steroid intake in the last three months,\n* estimated glomerular filtration rate (eGFR) \\\u003C30 ml\u002Fmin\u002Fm2,\n* active dental caries or invasive dental procedure,\n* peripheral vascular disease (ABI \\\u003C 0.7),\n* bilateral foot involvement,\n* pregnant\u002F lactating women and\n* those who had recently received antiresorptive agents (in the previous 12 months).\n* Negative consent","ALL","18 Years",{"count":71,"type":72},80,"ESTIMATED","INTERVENTIONAL",[75],"NA","Charcot neuroarthropathy (CN) is a condition in diabetic patients characterized by foot swelling, redness, and a temperature difference exceeding 2˚C compared to the other foot. The study compares two treatments: a standard knee-high, non-removable total contact cast (TCC) and a non-removable knee-high walker. Both aim to immobilize and offload the foot to promote healing. The study will involve diabetic patients with specific criteria and exclude those with conditions like foot ulcers or severe kidney issues. Patients will be randomly assigned to one of the two treatments and followed for up to a year. The primary goal is to see how many patients achieve remission within six months, with secondary goals including remission within twelve months, time to remission, quality of life, and foot health. Statistical tests will be used to analyze the data and determine the effectiveness of each treatment. The study aims to improve CN treatment and provide better options for patients.",[78],"Charcot Neuroarthropathy",[78,22,80,27,81,82,83],"Diabetic Foot","Vibration Perception Threshold","Peripheral Neuropathy","Diabetes Mellitus","2025-01-18",{"date":86,"type":87},"2025-01-22","ACTUAL",{"date":89,"type":87},"2024-12-11",{"date":91,"type":72},"2027-03-31",{"name":5,"class":6},1]