Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-28 @ 9:33 PM
Study NCT ID:
NCT02308059
Status:
COMPLETED
Last Update Posted:
2014-12-04
First Post:
2014-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonographic Evaluation of Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores on the visual analog scale', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Neuropathic pain scores on the Leeds Assessment of Neuropathic Symptoms and Signs pain scale', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Peripheral Neuropathy']}, 'descriptionModule': {'briefSummary': 'The current study aimed to evaluate the cross-sectional area (CSA) of peripheral nerves in people with diabetic peripheral neuropathy using ultrasonography and correlate the CSA with clinical and demographic data.', 'detailedDescription': 'Patients with diabetic peripheral neuropathy (n=53) and a matched healthy control group (n=53) underwent blinded ultrasonography imaging of the sciatic, tibial and median nerves. Matching was performed according to patient body mass index (BMI), sex and age. CSAs of the nerves were recorded, and the associations between pain intensity (measured with a visual analog scale \\[VAS\\]), the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale, diabetes mellitus duration, BMI, HbA1c and blood glucose levels were evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients in a University Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes mellitus\n* Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scores ≥ 12\n* probable diabetic peripheral neuropathy according to the diabetic peripheral neuropathy criteria.\n\nExclusion Criteria\n\n* type 1 diabetes mellitus\n* hypothyroidism\n* LANSS pain scale scores \\< 12\n* body mass index (BMI) \\> 35\n* current pregnancy\n* histories of hereditary neuropathy, inflammatory neuropathy, nerve trauma, or other known causes of polyneuropathy; and the use of anti-neuropathic drugs.'}, 'identificationModule': {'nctId': 'NCT02308059', 'briefTitle': 'Ultrasonographic Evaluation of Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Diabetic Peripheral Neuropathy: Correlation Between Ultrasound Findings and Clinical Features', 'orgStudyIdInfo': {'id': 'TF2012BAP13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with diabetes mellitus', 'description': 'Group I; the patients with diabetes mellitus who had peripheral neuropathy as diagnosed.', 'interventionNames': ['Other: Ultrasonographic evaluation of nerves in diabetic patients']}, {'label': 'Control', 'description': 'Group II; healthy volunteers', 'interventionNames': ['Other: Ultrasonographic evaluation of nerves of healthy volunteers']}], 'interventions': [{'name': 'Ultrasonographic evaluation of nerves in diabetic patients', 'type': 'OTHER', 'otherNames': ['ultasonographic evaluation'], 'description': 'Ultrasonographic evaluation of peripheral nerves in patients with diabetes mellitus which have peripheral neuropathy', 'armGroupLabels': ['Patients with diabetes mellitus']}, {'name': 'Ultrasonographic evaluation of nerves of healthy volunteers', 'type': 'OTHER', 'description': 'evaluation of peripheral nerves and correlated with group I', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bayram Kelle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Çukurova University, Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Bayram Kelle', 'investigatorAffiliation': 'Cukurova University'}}}}