Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-29 @ 9:48 PM
Study NCT ID:
NCT01431066
Status:
COMPLETED
Last Update Posted:
2014-03-03
First Post:
2011-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ActiPatch Plantar Fasciitis Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036981', 'term': 'Fasciitis, Plantar'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005534', 'term': 'Foot Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-27', 'studyFirstSubmitDate': '2011-09-07', 'studyFirstSubmitQcDate': '2011-09-07', 'lastUpdatePostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS) for pain', 'timeFrame': '4 Weeks Follow-up'}], 'secondaryOutcomes': [{'measure': 'Visual analog scale for pain', 'timeFrame': '26 weeks'}, {'measure': 'Foot and ankle disability index', 'timeFrame': '26 weeks'}, {'measure': 'Tegner activity scale', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Plantar Fasciitis', 'Plantar Fasciopathy']}, 'descriptionModule': {'briefSummary': 'Plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals in the workplace who must stand for prolonged periods of time, and athletes. It can be disabling. There is no single accepted treatment course that is recommended in the literature.\n\nThe use of pulsed radio-frequency electromagnetic (PRFE) devices has been proposed as a treatment option in chronic soft-tissue injury due to its ability to reduce pain and inflammation.\n\nThe proposed study will investigate the efficacy of the use of a PRFE device for the treatment of chronic heel pain using a double blind randomized placebo controlled design study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with diagnosis of plantar fasciitis agreeing to participate\n* Over 18 years old\n* Able to wear unit and keep data up-to-date records of use\n* Agree to forgo additional treatments during the study period\n\nExclusion Criteria:\n\n* Patients who have refused, are unable to give or have withdrawn consent\n* Patients with heel pain present less than 3 months'}, 'identificationModule': {'nctId': 'NCT01431066', 'briefTitle': 'ActiPatch Plantar Fasciitis Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Continuous Low Energy Pulsed Radio Frequency Electromagnetic Field Therapy for the Treatment of Plantar Fasciopathy', 'orgStudyIdInfo': {'id': 'H11-01828'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Sham device that resembles the Actipatch PRFE device, including the light that illuminates when active, but the transmitting function has been disabled.', 'interventionNames': ['Device: Sham pulsed radio-frequency electromagnetic device']}, {'type': 'EXPERIMENTAL', 'label': 'Actipatch', 'description': 'Use of the Actipatch PRFE device that is integrated into a viscoelastic heel pad for the treatment of plantar fasciopathy', 'interventionNames': ['Device: ActiPatch PRFE Device']}], 'interventions': [{'name': 'Sham pulsed radio-frequency electromagnetic device', 'type': 'DEVICE', 'description': 'Disabled PRFE device', 'armGroupLabels': ['Control']}, {'name': 'ActiPatch PRFE Device', 'type': 'DEVICE', 'description': 'Actipatch PRFE device', 'armGroupLabels': ['Actipatch']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T 1Z3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Division of Sports Medicine', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioElectronics Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}