Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT01017406
Status:
UNKNOWN
Last Update Posted:
2011-07-27
First Post:
2009-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heel Cushion for Plantar Fasciitis
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-26', 'studyFirstSubmitDate': '2009-11-17', 'studyFirstSubmitQcDate': '2009-11-19', 'lastUpdatePostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS score', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Compliance', 'timeFrame': '2 years'}, {'measure': 'Satisfaction score', 'timeFrame': '2 years'}, {'measure': 'Foot functional score : FHSQ score', 'timeFrame': '2 years'}, {'measure': 'Number of rescue pain killer', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['plantar fasciitis', 'heel cushion', 'treatment'], 'conditions': ['Plantar Fasciitis']}, 'descriptionModule': {'briefSummary': 'The investigators study aim to evaluate the efficacy of PSU heel cushion in treatment of plantar fasciitis. The investigators will do a randomized controlled trial in patient with plantar fasciitis compared with stretching exercise alone. The outcome measurement include heel pain improvement, compliance, satisfaction, foot functional score at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with plantar fasciitis\n\nExclusion Criteria:\n\n* Rheumatologic problem such as rheumatoid arthritis\n* Latex allergy\n* Pregnancy\n* Previous surgery around foot and ankle'}, 'identificationModule': {'nctId': 'NCT01017406', 'briefTitle': 'Heel Cushion for Plantar Fasciitis', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'PSU Heel Cushion for Treatment of Plantar Fasciitis:A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '52-118-11-1-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plantar fascia stretching exercise', 'description': 'Patient perform plantar fascia stretching 3 times per day', 'interventionNames': ['Device: PSU heel cushion and plantar fascia specific stretching exercise']}], 'interventions': [{'name': 'PSU heel cushion and plantar fascia specific stretching exercise', 'type': 'DEVICE', 'description': '* Wear heel cushion during daily activity\n* Plantar fascia stretching exercise 3 times per day', 'armGroupLabels': ['Plantar fascia stretching exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Prince of Songkla university', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}], 'overallOfficials': [{'name': 'Suntorn Wongsiri, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of orthopedic surgery, faculty of medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Boonsin Tangtrakulwanich', 'oldOrganization': 'Department of Orthopedic Surgery, Faculty of Medicine'}}}}