[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100303514":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":35,"centralContacts":40,"locations":49,"responsibleParty":77,"collaborators":27,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":27,"enrollmentInfo":90,"targetDuration":27,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":27,"overallStatus":51,"whyStopped":27,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Anatomical injection","ACTIVE_COMPARATOR","Once patient has been randomized, if placed in the anatomically-guided injection group, the medial band of the plantar fascia origin on the calcaneus will be palpated and marked approximately. In the clinical setting, a sham ultrasound machine will be utilized to \"locate\" the plantar fascia keeping the patient blinded to the treatment modality. The area will then be prepped with alcohol to the medial heel and utilizing a medial approach, an injection of 0.5 cc 0.5% bupivacaine, 0.5 cc dexamethasone and 0.25 cc triamcinolone acetamide 40 mg\u002FmL will be administered into the area surrounding the plantar fascia. The area will then be cleaned will alcohol and dressed with a small elastic bandage.",[13,14],"Procedure: Local Steroid Injection into the plantar heel","Procedure: Anatomical Guided injection",{"label":16,"type":17,"description":18,"interventionNames":19},"Ultrasound Guided Injection","EXPERIMENTAL","Once patient has been randomized, if placed in the USGI group, the patient will be scheduled for an ultrasound therapy in the radiology department at Penn Presbyterian Medical Center. In this setting, the patient will be informed that in order to keep them blinded, that all patients must have either injection performed in the radiology department and that the ultrasound machine utilized will either be on or off during the injection keeping the patient blinded to the treatment modality. The area will then be prepped with alcohol to the medial heel and utilizing a medial approach, an injection of 0.5 cc 0.5% bupivacaine, 0.5 cc dexamethasone and 0.25 cc triamcinolone acetamide 40 mg\u002FmL will be administered into the area surrounding the plantar fascia. The area will then be cleaned will alcohol and dressed with a small elastic bandage.",[13,20],"Procedure: Ultrasound Guided Injection",[22,28,31],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Local Steroid Injection into the plantar heel","Injections consisting of 0.5 ml 0.25% bupivacaine plain, 0.5 ml dexamethasone phosphate, and 0.5 ml triamcinolone acetonide 40 mg\u002Fml.",[9,16],null,{"type":23,"name":16,"description":29,"armGroupLabels":30,"otherNames":27},"Execution of the USGI will employ an actual diagnostic US machine (Voluson E8 Expert, General Electric Company, Boston, MA) and a plantarmedial approach",[16],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":27},"Anatomical Guided injection","Execution of the ATGI will employ a sham diagnostic US machine and a plantarmedial approach.",[9],[36],{"name":37,"affiliation":38,"role":39},"Donald S Malay, DPM","Penn Presbyterian Medical Center","PRINCIPAL_INVESTIGATOR",[41,45],{"name":37,"role":42,"phone":43,"phoneExt":27,"email":44},"CONTACT","4848440755","malaydsm@gmail.com",{"name":46,"role":42,"phone":47,"phoneExt":27,"email":48},"Hye R Kim, DPM","443-765-6588","hearin86@gmail.com",[50],{"facility":38,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-75.16362,39.95238,{"lat":61,"lon":60},[64,66,69,71,73,75],{"name":37,"role":42,"phone":65,"phoneExt":27,"email":44},"484-844-0755",{"name":67,"role":68,"phone":27,"phoneExt":27,"email":27},"Brittany Winfield, DPM","SUB_INVESTIGATOR",{"name":70,"role":68,"phone":27,"phoneExt":27,"email":27},"Lauren E Pruner, DPM",{"name":72,"role":68,"phone":27,"phoneExt":27,"email":27},"Raafae Hussain, DPM",{"name":74,"role":68,"phone":27,"phoneExt":27,"email":27},"Paul Niziolek, MD",{"name":76,"role":68,"phone":27,"phoneExt":27,"email":27},"Viviane Khoury, MD",{"type":78,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100303514","plantar-fasciitis-randomized-clinical-control-trial-100303514",false,"NCT03231150","Plantar Fasciitis Randomized Clinical Control Trial","Randomized Clinical Study to Evaluate Ultrasound Guided Injection Therapy Versus Topographic Injection Therapy for Plantar Fasciitis","PF-RCT","Inclusion Criteria:\n\n* Pain on palpation along the proximal plantar fascia with or without radiographic evidence of a plantar calcaneal bone spur\n* ≥18 years of age\n* Male or non-pregnant female of any ethnicity or race\n* Active, former or non smoker\n* With or without peripheral vascular disease without lower extremity intermittent claudication or rest pain\n* With or without diabetes mellitus without polyneuropathy\n* With or without collagen vascular disease without lower extremity wound formation.\n\nExclusion Criteria:\n\n* Known drug or alcohol dependence\n* Chronic pain syndrome or lumbosacral radiculitis\n* Neurological condition that requires the use of analgesic medications or anti-seizure or neuroleptic medications\n* Peripheral vascular disease that results in rest pain or intermittent claudication or venous stasis ulceration\n* Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel as viewed radiographically\n* Pregnant females\n* Known allergy to any of the components of the injection therapy\n* Previously suffered a rupture or surgery of the plantar fascia within the 5 years preceding participation in the investigation\n* Existing or prior osteomyelitis of the involved calcaneus\n* Unable to consent to participation in clinical research or currently be involved in another clinical investigation.",true,"ALL","18 Years",{"count":91,"type":92},62,"ESTIMATED","INTERVENTIONAL",[95],"NA","The primary aim of this clinical experiment is to compare, in terms of pain relief measured using the 10-cm visual analog scale (VAS) pain score (5-7), the clinical results of ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of corticosteroid for the treatment of proximal PF. Secondary aims will be to compare foot-related quality of life, as measured using the Foot Function Index (FFI)and the Bristol Foot Score (BFS), between the injection groups, and also to compare the pre-injection to late-term post-injection thickness of the plantar fascia as measured in the nested USGI group.",[98],"Plantar Fascitis","2025-10-08",{"date":101,"type":102},"2025-10-10","ACTUAL",{"date":104,"type":102},"2017-03-28",{"date":106,"type":92},"2026-10-31",{"name":5,"class":6},1]