[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100378633":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":60,"collaborators":23,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":23,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":23,"enrollmentInfo":70,"targetDuration":23,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":23,"overallStatus":46,"whyStopped":23,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Minnesota","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Soft Cast with a Removable Cam Boot","EXPERIMENTAL","Patients with a foot, ankle, or lower leg ulcer (which we expect to be mostly diabetic foot ulcers) will be provided with a total contact soft cast with removable cam boot.",[13,14],"Device: Total Contact Soft Cast","Device: Cam Boot",{"label":16,"type":10,"description":17,"interventionNames":18},"Soft Cast without a Removable Cam Boot","Patients with a foot, ankle, or lower leg ulcer (which we expect to be mostly diabetic foot ulcers) will be provided with a total contact soft cast.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Conventional","NO_INTERVENTION","Patients with a foot, ankle, or lower leg ulcer (which we expect to be mostly diabetic foot ulcers) will use conventional offloading including total contact casting, removable cast boots (cam boots), CROW boots, bracing, AFO's, offloading shoes, insoles, padding, shoe modifications, crutches, wheelchairs, rollabout, and surgical correction.",null,[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"DEVICE","Total Contact Soft Cast","The total contact soft cast will consist of wound dressing of choice to the ulcer and a plantar foot accommodative offloading felt pad for all foot ulcers, with 4x4 gauze pads added to the arch to create a rocker bottom for metarsophalangeal joint (MPJj) and plantar heel ulcers. The next layers will be:\n\n* Unna boot from MPJs to just below the knee,\n* Sterile Kerlix from MPJs to just below the knee\n* Sterile 4 inch Kling wrap from the MPJs to just below the knee,\n* Four inch coban from MPJs to just below the knee, and\n* Ace wraps from MPJs to just below the knee",[9,16],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":23},"Cam Boot","Removable Diabetic cam boot will be used in patients willing and capable of using it. If patient does not want to use Diabetic cam boot then surgical shoe or regular shoe would be options.",[9],[35],{"name":36,"affiliation":5,"role":37},"Joseph Schuster, DPM","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":23,"email":43},"Joseph Schuster","CONTACT","612-273-9400","schus122@umn.edu",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Minneapolis","Minnesota","55454","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-93.26384,44.97997,{"lat":56,"lon":55},[59],{"name":36,"role":41,"phone":42,"phoneExt":23,"email":43},{"type":61,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100378633","total-contact-soft-cast-in-diabetic-foot-ulcers-100378633",false,"NCT04210089","Total Contact Soft Cast in Diabetic Foot Ulcers","Inclusion Criteria:\n\n\\- Any adult with a diabetic foot ulcer\n\nExclusion Criteria:\n\n* Allergy to Calamine or Zinc oxide\n* Inability to have leg wrapped\n* Inability to be seen weekly or as needed\n* Unable or unwilling to consent\n* Prisoners\n* Persons lacking capacity to consent","ALL","18 Years",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75],"NA","To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.",[78,79,80,81,82,83,84,85],"Diabetic Foot Ulcer","Diabetes Mellitus","Foot Ulcer","Foot Ulcer, Diabetic","Ulcer","Ulcer Foot","Ulcer, Leg","Ankle Ulcer","2025-12-09",{"date":88,"type":89},"2025-12-15","ACTUAL",{"date":91,"type":89},"2020-10-13",{"date":93,"type":72},"2026-10-01",{"name":5,"class":6},1]