Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT03560505
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2018-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-resolution Ultrasound in Lower Extremity Nerves and Common Fibular Neuropathies.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020427', 'term': 'Peroneal Neuropathies'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2018-06-07', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nerve cross-sectional area (CSA)', 'timeFrame': '1 year', 'description': 'The nerve cross-sectional area within the hyperechoic epineurium measured with ultrasound machine software.'}, {'measure': 'Common fibular nerve fascicle properties', 'timeFrame': '1 year', 'description': 'The amount of visible fascicles and fascicle CSA of the common fibular nerve at measurement sites.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound reference material', 'Sensitivity', 'Specificity', 'Common fibular compression neuropathy', 'Type 2 diabetes polyneuropathy', 'Intra-rater reliability', 'Inter-rater reliability'], 'conditions': ['Ultrasonography', 'Peroneal Neuropathies']}, 'descriptionModule': {'briefSummary': 'This study establishes reference material of selected lower extremity nerves at pre-defined sites with high-resolution ultrasound. Furthermore in this study, high-resolution ultrasound of patients with common fibular compression neuropathy and patients with type 2 diabetic polyneuropathy involving the common fibular nerve will be examined and compared to healthy controls. High-resolution ultrasound measurements will be correlated with history, clinical information and electrophysiological data.', 'detailedDescription': 'The usual diagnostic work-up of patients referred for lower-extremity neuropathy includes clinical examination, biochemical tests (blood and cerebrospinal fluid), electrophysiological assessment and if necessary nerve biopsy. The electrophysiological assessment usually consists of nerve conduction studies (NCS) and electromyography (EMG). While electrophysiological measurements generally give information about the function of nerves, high-resolution ultrasound may provide information about the structure of nerves.\n\nHigh-resolution ultrasound examination has shown promising results as a supplementary tool in the diagnostic work-up of various peripheral neuropathies. The clinical utility of ultrasound in the diagnosis of common fibular neuropathies, however, calls for further elucidation.\n\nThis study establishes reference material of selected lower extremity nerves at pre-defined sites with high-resolution ultrasound. Furthermore in this study, high-resolution ultrasound of patients with common fibular compression neuropathy and patients with type 2 diabetic polyneuropathy involving the common fibular nerve will be examined and compared to healthy controls, as well as each other. High-resolution ultrasound measurements will be correlated with history, clinical information and electrophysiological data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with common fibular compression neuropathy and patients with type 2 diabetes polyneuropathy involving the common fibular nerve', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes polyneuropathy common fibular nerve affection or\n* Common fibular nerve compression neuropathy\n\nExclusion Criteria:\n\n* Lumbar radiculopathy\n* Other competing lower extremity peripheral neuropathy\n* Peripheral vascular disease\n* Hypothyroidism'}, 'identificationModule': {'nctId': 'NCT03560505', 'briefTitle': 'High-resolution Ultrasound in Lower Extremity Nerves and Common Fibular Neuropathies.', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'A Prospective Study of High-resolution Ultrasonography in Examination of Lower Extremity Peripheral Nerves in Patients With Compression Neuropathies and in Healthy Controls.', 'orgStudyIdInfo': {'id': 'USCF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Common fibular compression neuropathy', 'description': 'Patients referred for electrophysiological assessment of common fibular compression neuropathy with subsequent confirmation of referral diagnosis.\n\nIntervention: Ultrasound protocol.', 'interventionNames': ['Diagnostic Test: Ultrasound protocol']}, {'label': 'Type 2 diabetes polyneuropathy', 'description': 'Patients with type 2 diabetes referred for polyneuropathy involving the common fibular nerve with subsequent confirmation of referral diagnosis.\n\nIntervention: Ultrasound protocol.', 'interventionNames': ['Diagnostic Test: Ultrasound protocol']}], 'interventions': [{'name': 'Ultrasound protocol', 'type': 'DIAGNOSTIC_TEST', 'description': 'High-resolution ultrasound protocol at pre-defined sites bilaterally. Pre-defined sites: Sciatic nerve (proximal and distal), tibial nerve (proximal and distal), common fibular nerve (proximal and distal), superficial fibular nerve (proximal and distal) and sural nerve (proximal and distal).', 'armGroupLabels': ['Common fibular compression neuropathy', 'Type 2 diabetes polyneuropathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Clinical Neurophysiolgy, Department of Neurology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Erisela Qerama Montvilas, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Clinical Neurophysiology, Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sándor Beniczky', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sándor Beniczky', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}