Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT04692961
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2020-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change in the Lower Leg Muscle Stiffness Following Peroneal Artery-based Flap
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054459', 'term': 'Elasticity Imaging Techniques'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-17', 'studyFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2020-12-30', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower Leg Muscle stiffness', 'timeFrame': '6 months', 'description': 'Lower leg muscle stiffness after peroneal artery-based flap harvested; Name of measurement: elastic modulus; Unit: kPa'}], 'secondaryOutcomes': [{'measure': 'American Orthopedic Foot and Ankle (AOFAS) scale', 'timeFrame': '6 months', 'description': 'AOFAS scale change after peroneal artery-based flap harvested, highest score:100, lowest score: 0; A higher score means a better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elastography; Donor site morbidity'], 'conditions': ['Donor Site Complication', 'Muscle; Ischemic']}, 'descriptionModule': {'briefSummary': 'In the field of reconstructive microsurgery, donor site morbidity after free flap harvest is one of the key factors to consider when choosing among different options of free flap. Peroneal artery-based free flap, such as fibula flap or peroneal flap, is one of the popular options of free flap. There are a plenty of literature using a variety of modalities to evaluate the donor site morbidity after free fibula harvest, such as gait analysis. Elastography has been used to evaluate the stiffness change of soft tissue, such as skeletal muscle, or liver. The purpose of this study is to use elastography to evaluate the stiffness of lower leg muscle after peroneal artery-based free flap harvest.', 'detailedDescription': 'A total of twenty-three patients will be recruited at National Taiwan University Hospital Yunlin Branch. All of them will receive fibula flap or peroneal flap harvest operations. At the time points of pre-operation, 1-month post-operation, 3-month post-operation, and 6-month post-operation, the muscles of both legs of each patient will be evaluated by elastography, and the function of both legs will be evaluated by American Orthopedic Foot and Ankle Score (AOFAS). Paired t-test will be used to compare the results of each evaluations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No previous major operations over both legs\n* Able to walk freely during daily life\n* Going to receive peroneal artery-based free flap harvested from one leg\n\nExclusion Criteria:\n\n* Previous major operations over either leg\n* Unable to walk freely during daily life'}, 'identificationModule': {'nctId': 'NCT04692961', 'briefTitle': 'Change in the Lower Leg Muscle Stiffness Following Peroneal Artery-based Flap', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Change in the Lower Leg Muscle Stiffness Following Peroneal Artery-based Flap: An Elastography Ultrasonographic Study', 'orgStudyIdInfo': {'id': '202009077RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients after free flap harvested', 'description': 'Patients receiving peroneal artery-based free flap harvest', 'interventionNames': ['Device: Elastography']}], 'interventions': [{'name': 'Elastography', 'type': 'DEVICE', 'description': 'Use elastography to evaluate the stiffness of lower leg muscle after peroneal artery-based free flap harvested', 'armGroupLabels': ['Patients after free flap harvested']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Douliu', 'state': 'Yunlin County', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital Yunlin Branch', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}], 'overallOfficials': [{'name': 'Ying-Sheng Lin, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}