Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT03857334
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2018-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Platelet Rich Plasma in Plantar Fasciitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2018-04-27', 'studyFirstSubmitQcDate': '2019-02-26', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean daily pain measured with a visual analog scale from 0 to 10', 'timeFrame': '6 months', 'description': 'Comparison of pain intensity, measured with a visual analog scale from 0 to 10'}], 'secondaryOutcomes': [{'measure': 'Pain intensity during the first steps of the day measured with a visual analog scale from 0 to 10', 'timeFrame': '6 months', 'description': 'Measured with a visual analog scale from 0 to 10'}, {'measure': 'Pain intensity on direct compression measured with a visual analog scale from 0 to 10', 'timeFrame': '6 months', 'description': 'Constant intensity of the compression, measured with a visual analog scale from 0 to 10'}, {'measure': 'Impairment of walking function', 'timeFrame': '6 months', 'description': 'Foot function index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plantar Fascitis']}, 'referencesModule': {'references': [{'pmid': '34844893', 'type': 'DERIVED', 'citation': 'Breton A, Leplat C, Picot MC, Aouinti S, Taourel P, Laffont I, Julia M, Cyteval C. Prediction of clinical response to corticosteroid or platelet-rich plasma injection in plantar fasciitis with MRI: A prospective, randomized, double-blinded study. Diagn Interv Imaging. 2022 Apr;103(4):217-224. doi: 10.1016/j.diii.2021.10.008. Epub 2021 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'Plantar fasciitis is a common pathology among podiatry moreover the healing time takes several months.\n\nThe main aim of this study is to evaluate the efficacy of a injection of Platelet-Rich Plasma (PRP) versus corticosteroid injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Plantar fasciitis\n* Average VAS greater than or equal to 5/10\n* Resistance of medical reference treatment\n\nExclusion Criteria:\n\n* Other plantar lesion find on RMI\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03857334', 'acronym': 'APOPLANT', 'briefTitle': 'Efficacy of Platelet Rich Plasma in Plantar Fasciitis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Plantar Fasciitis Treatment: Double Blinded Randomized Control Study of the Efficacy of an Injection of Platelet Rich Plasma (PRP) Versus an Infiltration of Corticosteroids', 'orgStudyIdInfo': {'id': 'UF 8737'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'interventionNames': ['Biological: Injection of autologous platelet rich plasma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'interventionNames': ['Drug: Injection of cortivazol : Altim®']}], 'interventions': [{'name': 'Injection of autologous platelet rich plasma', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Arm A']}, {'name': 'Injection of cortivazol : Altim®', 'type': 'DRUG', 'description': 'Corticosteroids', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34090', 'city': 'Montpellier', 'country': 'France', 'facility': 'Montpellier University Hosîtal', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}