Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-28 @ 3:35 PM
Study NCT ID:
NCT04672668
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between the Volume Flow of the CFA After Angioplasty of Critical Ischemic Limb and Wound Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018616', 'term': 'Ultrasonography, Doppler, Duplex'}], 'ancestors': [{'id': 'D018608', 'term': 'Ultrasonography, Doppler'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-13', 'studyFirstSubmitDate': '2020-12-13', 'studyFirstSubmitQcDate': '2020-12-13', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound healing', 'timeFrame': '12 months', 'description': 'physical examination'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Wound Heal, Duplex Volume Flow']}, 'descriptionModule': {'briefSummary': 'in our study we are examining the volume flow of the common femoral artery before and after angigraphy of a critical ischemic limb, as a predictor for wound healing after the treatment', 'detailedDescription': 'All patients with threatened limbs, that was decided upon to have angioplasty will be asked to sign consent form to participate in this study.\n\nBefore having the angioplasty, all participants will be examined with ultrasound duplex to determent their common femoral artery volume flow. Day after the angioplasty, they will be reexamined (this is the usual practice) to detriment the new volume flow in the CFA.\n\nThe participents examinations in the outpatient clinics will be documented and time for healing will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with threatened limbs, having angioplasty .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with threatened limbs, that was decided upon to have angioplasty .\n\nExclusion Criteria:\n\n* those who are not willing to sign a consent form to participate in this study'}, 'identificationModule': {'nctId': 'NCT04672668', 'briefTitle': 'Correlation Between the Volume Flow of the CFA After Angioplasty of Critical Ischemic Limb and Wound Healing', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Correlation Between the Volume Flow of the CFA After Angioplasty of Critical Ischemic Limb and Wound Healing', 'orgStudyIdInfo': {'id': 'SHEBA-20-7318-CP-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'duplex ultrasound for the common femoral artery', 'type': 'DIAGNOSTIC_TEST', 'description': 'duplex ultrasound for the common femoral artery before and after the angiography'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Health Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'moshe halak, dr', 'role': 'STUDY_CHAIR', 'affiliation': 'sheba health center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dr', 'investigatorFullName': 'Dr. Chen Speter', 'investigatorAffiliation': 'Sheba Medical Center'}}}}