Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-04-02 @ 2:47 AM
Study NCT ID:
NCT06384859
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS', 'timeFrame': '6 week, 3 months, 6 months and 1 year after treatment', 'description': 'Visual Analogue Scale'}], 'secondaryOutcomes': [{'measure': 'VAS-FA', 'timeFrame': '6 week, 3 months, 6 months and 1 year after treatment', 'description': 'Visual analogue scale foot and ankle'}, {'measure': 'FFI', 'timeFrame': '6 week, 3 months, 6 months and 1 year after treatment', 'description': 'Foot functional index'}, {'measure': 'FAAM', 'timeFrame': '6 week, 3 months, 6 months and 1 year after treatment', 'description': 'Foot and Ankle Ability Measure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic insertional Achilles tendinopathy', 'extracorporeal shockwave therapy', 'platelet rich plasma'], 'conditions': ['Insertional Achilles Tendinopathy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. The main questions it aims to answer are:\n\nDoes ESWT combined with PRP treatment reduce the symptom and improve functional score after treatment? What medical complication do participants have when receive the treatment?\n\nResearchers will compare ESWT combined with PRP to ESWT treatment alone to see if ESWT combined with PRP works to treat chronic insertional tendinopathy.\n\nParticipants will:\n\n* Receive ESWT once a week for 4 weeks then receive PRP injection at a week later or ESWT once a week for 4 weeks\n* Visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with insertional Achilles tendinopathy\n* Had symptom more than 6 months\n* Failed other standard conservative treatment (rest, medication, activity modification, stretching exercise, and heel lift orthosis)\n\nExclusion Criteria:\n\n* Receive corticosteroid injection at the Achilles insertion\n* History of infection around ankle and heel\n* Has neurological deficit\n* Has a contraindication for ESWT(hemophilia, coagulopathy or foot and ankle malignancy)'}, 'identificationModule': {'nctId': 'NCT06384859', 'briefTitle': 'Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy', 'orgStudyIdInfo': {'id': 'Pending'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESWT + PRP', 'description': 'Receive ESWT once a week for 4 weeks and PRP injection at a week later', 'interventionNames': ['Device: ESWT', 'Biological: PRP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ESWT', 'description': 'Receive ESWT once a week for 4 weeks', 'interventionNames': ['Device: ESWT']}], 'interventions': [{'name': 'ESWT', 'type': 'DEVICE', 'description': 'Receive ESWT once a week for 4 weeks', 'armGroupLabels': ['ESWT', 'ESWT + PRP']}, {'name': 'PRP', 'type': 'BIOLOGICAL', 'description': 'Receive PRP injection at week 5', 'armGroupLabels': ['ESWT + PRP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Ratchathewi', 'state': 'Bangkok', 'country': 'Thailand', 'contacts': [{'name': 'Prapan Wongrungrote, MD', 'role': 'CONTACT', 'email': 'prapanw197@gmail.com', 'phone': '+66 0810688654'}, {'name': 'Sukij Laohajaroensombat, MD', 'role': 'CONTACT', 'email': 'sukij.lah@mahidol.ac.th', 'phone': '+66 022011589'}], 'facility': 'Ramathibodi hospital', 'geoPoint': {'lat': 13.759, 'lon': 100.53358}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}