Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-29 @ 4:40 PM
Study NCT ID:
NCT06885892
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2025-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posterior Tibial Artery Perforator-Pedicled Propeller Flaps in Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-03-09', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'flaps observation', 'timeFrame': '12-24months', 'description': 'flaps color :normal;pale;cyanoderma'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['the lower leg', 'soft tissue defects', 'perforator flaps', 'propeller flaps', 'doppler ultrasound'], 'conditions': ['Trauma Patients with Soft Tissue Defects']}, 'referencesModule': {'references': [{'pmid': '32123981', 'type': 'BACKGROUND', 'citation': 'Lin J, Zhou F, Sun YD, Gao YS, Li HZ, Zheng HP, Zhang YF, Li QF, Ward PJ, Yang YL, Liu CY. Modified Anterior Tibial Artery Perforator-Pedicled Propeller Flap for Soft-Tissue Coverage of the Ankle and Heel. World J Surg. 2020 Jul;44(7):2237-2242. doi: 10.1007/s00268-020-05452-y.'}, {'pmid': '18046150', 'type': 'BACKGROUND', 'citation': 'Jakubietz RG, Jakubietz MG, Gruenert JG, Kloss DF. The 180-degree perforator-based propeller flap for soft tissue coverage of the distal, lower extremity: a new method to achieve reliable coverage of the distal lower extremity with a local, fasciocutaneous perforator flap. Ann Plast Surg. 2007 Dec;59(6):667-71. doi: 10.1097/SAP.0b013e31803c9b66.'}]}, 'descriptionModule': {'briefSummary': 'Soft tissue defects in the lower leg remain a challenge for surgeons due to frequent bone exposure and paucity of soft tissues. The goal in this study was to evaluate the surgical technique and clinical significance of posterior tibial artery perforator-pedicled propeller flaps for reconstruction of defects in the lower leg.', 'detailedDescription': 'The construction of the lower extremity defects with exposed bone and tendon is considered as the biggest challenge of all body regions in many plastic and reconstructive surgeons. The lower leg regions are in visible areas. Defects recovery and aesthetic consideration should be considered at the same time with the development of the economy and society. Although free flaps have been used to reconstruct these defects, some disadvantages still exist, such as needing microinstruments, long operation time and none like-with-like repair. In this article, a series of patients with soft tissue defects in the lower leg were transplanted with posterior tibial artery perforator-pedicled propeller flaps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.age range :10-80years. 2. in good overall heath without severe comorbidities. 3. posterior perforator tibial artery is no damage.\n\nExclusion Criteria:\n\n1. age range \\<10years or \\>80years.\n2. with severe comorbidities\n3. Posterior perforator tibial artery of panticipants is damage'}, 'identificationModule': {'nctId': 'NCT06885892', 'briefTitle': 'Posterior Tibial Artery Perforator-Pedicled Propeller Flaps in Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Xuzhou Medical University'}, 'officialTitle': 'Posterior Tibial Artery Perforator-Pedicled Propeller Flaps for Reconstruction of the Defects in the Lower Leg（Case Series）', 'orgStudyIdInfo': {'id': 'XYFY2015-JS018-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'surgery', 'description': 'posterior tibial artery perforator-pedicled propeller flaps transplantation for soft-tissue defects', 'interventionNames': ['Procedure: Posterior Tibial Artery Perforator-Pedicled Propeller Flaps', 'Procedure: Perforator-Pedicled Propeller Flaps']}], 'interventions': [{'name': 'Posterior Tibial Artery Perforator-Pedicled Propeller Flaps', 'type': 'PROCEDURE', 'description': 'Posterior tibial artery perforator-pedicled propeller flaps are feasible, safe, and effective procedure in the reconstruction of the defects in the lower leg.', 'armGroupLabels': ['surgery']}, {'name': 'Perforator-Pedicled Propeller Flaps', 'type': 'PROCEDURE', 'description': 'Posterior Tibial Artery Perforator-Pedicled Propeller Flaps', 'armGroupLabels': ['surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221000', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Xuzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}