Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-04-24 @ 9:04 PM
Study NCT ID:
NCT03012750
Status:
COMPLETED
Last Update Posted:
2017-01-06
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Angiosome Perfusion After Tibial Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-04', 'studyFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2017-01-04', 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingress)', 'timeFrame': '12 months', 'description': 'Comparison of the fluorescence parameter Ingress in the direct and indirect revascularized angiosome before and after tibial bypass surgery'}, {'measure': 'Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingressrate)', 'timeFrame': '12 months', 'description': 'Comparison of the fluorescence parameter Ingressrate in the direct and indirect revascularized angiosome before and after tibial bypass surgery'}], 'secondaryOutcomes': [{'measure': 'Correlation of the wound healing rates with indirect and direct revascularization', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '29305093', 'type': 'DERIVED', 'citation': 'Rother U, Lang W, Horch RE, Ludolph I, Meyer A, Gefeller O, Regus S. Pilot Assessment of the Angiosome Concept by Intra-operative Fluorescence Angiography After Tibial Bypass Surgery. Eur J Vasc Endovasc Surg. 2018 Feb;55(2):215-221. doi: 10.1016/j.ejvs.2017.11.024. Epub 2018 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'Microcirculation should be assessed before and after tibial bypass surgery by intraoperative fluorescence angiography. According to this, the direct and the indirect angiosomes should be compared according to the individual microcirculatory improvement.', 'detailedDescription': 'Only patients at CLI stage Rutherford IV to VI with the necessity of tibial Bypass surgery will be included. Macrocirculation is measured by the ankle-brachial index (ABI). In order to assess the skin microcirculation intraoperative fluorescence angiography is used (SPY Elite™, NOVADAQ, Canada). The alteration of microcirculation is compared in direct and indirect revascularized angiosomes by calculation of the fluorescence parameters Ingress (IN) and Ingress rate (InR). Clinical Follow-up investigations will be performed and the wound healing rate is compared between the different revascularization methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at CLI Rutherford stages IV to VI\n* Patients with necessity of tibial Bypass surgery\n\nExclusion Criteria:\n\n* Allergy against indocyanine green\n* Iodine allergy\n* Contrast allergy\n* Penicillin allergy\n* Allergic diathesis\n* Liver insufficiency\n* Pregnancy\n* Hyperthyreosis\n* Pulmonary arterial hypertension'}, 'identificationModule': {'nctId': 'NCT03012750', 'briefTitle': 'Angiosome Perfusion After Tibial Bypass', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Erlangen'}, 'orgStudyIdInfo': {'id': 'SPY-Angiosome'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'foot perfusion', 'description': 'intravenous application of indocyanine green in patients receiving tibial Bypass surgery', 'interventionNames': ['Drug: Indocyanine Green']}], 'interventions': [{'name': 'Indocyanine Green', 'type': 'DRUG', 'description': 'Perioperative application of 0.1 mg ICG per kg Body weight', 'armGroupLabels': ['foot perfusion']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Erlangen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Ulrich Rother, Principal Investigator', 'investigatorFullName': 'Ulrich Rother', 'investigatorAffiliation': 'University Hospital Erlangen'}}}}