Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT00731068
Status:
COMPLETED
Last Update Posted:
2013-10-24
First Post:
2008-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Rich Plasma (PRP) as a Treatment for ACHILLES Tendon Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-23', 'studyFirstSubmitDate': '2008-08-05', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of symptoms / disease progress', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Achilles tendon'], 'conditions': ['Achilles Tendon Tear']}, 'descriptionModule': {'briefSummary': 'To review the influence of patient derived PRGF on the healing process of Achilles tendon after a surgical correction of a complete tear.', 'detailedDescription': 'Autologous platelet-rich matrices may aid in post surgical patients by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A complete tear of Achilles tendon\n* Age 18-50 years old\n\nExclusion Criteria:\n\n* under 18 year of age\n* pregnancy\n* physical or mental disabilities'}, 'identificationModule': {'nctId': 'NCT00731068', 'briefTitle': 'Platelet Rich Plasma (PRP) as a Treatment for ACHILLES Tendon Tears', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'PRP as a Treatment for ACHILLES Tendon Tears - Randomized-Double-Blind-Placebo Control Trail', 'orgStudyIdInfo': {'id': '2000'}, 'secondaryIdInfos': [{'id': 'MeirMc07om0090CTIL'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'PRGF', 'interventionNames': ['Biological: PRGF']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Biological: placebo']}], 'interventions': [{'name': 'PRGF', 'type': 'BIOLOGICAL', 'otherNames': ['platelet-derived preparation rich in growth factors'], 'description': 'injection of 6cc into injured area of tendon', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'BIOLOGICAL', 'otherNames': ['saline 0.9% nacl'], 'description': 'injection of 6 cc of saline into injured area', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Omer Mei Dan, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}