Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT00775333
Status:
COMPLETED
Last Update Posted:
2008-10-20
First Post:
2008-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nerve Entrapment in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-17', 'studyFirstSubmitDate': '2008-10-17', 'studyFirstSubmitQcDate': '2008-10-17', 'lastUpdatePostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensory function (Semmens-Weinstein), motor function (Abductor Pollicis Brevis (APB)-strength, grip strength)', 'timeFrame': 'Baseline, 6 weeks, 12 weeks, 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Pillar pain, cold intolerance, and patient satisfaction.', 'timeFrame': 'Baseline, 6 weeks, 12 weeks, 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carpal Tunnel Syndrome', 'Diabetes', 'APB strength', 'Sensory Function', 'Pillar Pain', 'Cold Intolerance', 'Patient Satisfaction'], 'conditions': ['Carpal Tunnel Syndrome', 'Entrapment Neuropathies', 'Nerve Compression Syndromes', 'Diabetes Complications']}, 'descriptionModule': {'briefSummary': 'The aim of this study is in a prospective, consecutive series of diabetic patients with carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having idiopathic carpal tunnel syndrome to compare the clinical results after carpal tunnel release.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred to a specialized hand clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis was based on clinical history and symptoms of carpal tunnel syndrome\n* Confirmed by nerve conduction studies.\n\nExclusion Criteria:\n\n* Other focal nerve entrapments\n* Cervical radiculopathy\n* Inflammatory joint disease\n* Renal failure\n* Thyroid disorders\n* Previous wrist fracture\n* Long-term exposure to vibrating tools.'}, 'identificationModule': {'nctId': 'NCT00775333', 'briefTitle': 'Nerve Entrapment in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Skane University Hospital'}, 'officialTitle': 'Clinical Outcomes of Surgical Release Among Diabetic Patients With Carpal Tunnel Syndrome. A Prospective Study With Matched Controls', 'orgStudyIdInfo': {'id': 'LU 508-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with diabetes and carpal tunnel syndrome'}, {'label': '2', 'description': 'Non-diabetic patients with carpal tunnel syndrome', 'interventionNames': ['Procedure: Outcome after carpal tunnel release']}], 'interventions': [{'name': 'Outcome after carpal tunnel release', 'type': 'PROCEDURE', 'description': 'Follow the outcome after standard carpal tunnel release in diabetic and non-diabetic patients', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Dept. of Hand Surgery, Malmo University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Lars Dahlin, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skane University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Niels Thomsen, MD', 'oldOrganization': 'Dept. of Hand Surgery, Malmo University Hospital, Sweden'}}}}