Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT01052805
Status:
UNKNOWN
Last Update Posted:
2011-10-21
First Post:
2010-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anatomy Study in Control Nerve From Normal Human
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'description': 'nerve from cadaveric donor nerve from nerve graft operation patient'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-10-20', 'studyFirstSubmitDate': '2010-01-18', 'studyFirstSubmitQcDate': '2010-01-19', 'lastUpdatePostDateStruct': {'date': '2011-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nerve', 'myelinated nerve', 'unmyelinated nerve'], 'conditions': ['Anatomy of Normal Human Nerves', 'Microscopic Study', 'Myelinated Nerve and Unmyelinated Nerve Study']}, 'descriptionModule': {'briefSummary': '1. To explore the pathology of nerve, vasculature in the normal control nerve\n2. Compare the pathology of control nerve and nerve from amputated limb of diabetes', 'detailedDescription': 'Diabetic foot occurs in 15% of diabetic population (3) and 15% of the diabetic foot patients end up with lower limb amputation. Peripheral neuropathy (sensory, motor and autonomic), peripheral vascular disease, trauma, infection and poor wound healing all contribute to diabetic foot problem.\n\nPeripheral neuropathy could be evaluated in a variety of ways, including vibratory thresholds, thermal thresholds, pressure perception thresholds, muscle strength. All these predict foot ulceration to some degree(1). Motor nerve conduction velocity is an independent predictor for the development of new foot ulcer in diabetic population.\n\nFor more detailed structural study of neuropathy in diabetic patient, we could use skin biopsy method. Skin biopsy with PGP9.5 immunohistochemistry has been demonstrated by ultrastructural studies to label the terminal portions of both small myelinated and unmyelinated nerve in the epidermis (5). Intra-epidermal nerve fiber (IENF) density is reduced in patient with impaired glucose tolerance and clinically overt diabetes (5). Previous IENF density study was performed in diabetic patients with sensory symptom but no foot ulcer. Now we tried to evaluate IENF density in severe diabetic foot patient who received below knee amputation. Skin biopsy will be performed at amputated leg. The skin biopsy area will be located at lateral side of distal leg, 10 cm above the lateral malleolus as previous protocol of our group (6). Underlying sural nerve and posterior tibial nerve will be also harvested for further ultra-structural study.\n\nWe had previous IRB for "Pathology of skin, nerve and vasculature in the amputated limb of diabetes". However, pathology of normal control nerve is important to compare the pathology of nerve from amputated limb of diabetes. For parotid cancer patients receiving radical parotidectomy, facial nerve is frequently sacrificed. Sural nerve is frequently harvested for reconstruction. Sural nerve is also frequently used in ther nerve construction surgery. During these operations, we could harvested 2 cm more sural nerve for normal nerve pathology study. For cadaveric donor patient, we also could harvest normal nerve for control study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cadaveric donor patients receiving nerve graft operation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cadaveric donor\n* Patients receiving nerve graft operation\n\nExclusion Criteria:\n\n* Patient with neurologic disease'}, 'identificationModule': {'nctId': 'NCT01052805', 'briefTitle': 'Anatomy Study in Control Nerve From Normal Human', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Anatomy Study in Control Nerve From Normal Human', 'orgStudyIdInfo': {'id': '200912006R'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'harvest nerve', 'description': 'harvest nerve from cadaveric donor and patients receiving nerve graft operation', 'interventionNames': ['Procedure: harvest nerve']}], 'interventions': [{'name': 'harvest nerve', 'type': 'PROCEDURE', 'description': 'harvest nerve from cadaveric donor and patients receiving nerve graft operation', 'armGroupLabels': ['harvest nerve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jung-Hsien Hsieh', 'role': 'CONTACT', 'email': 'jhhsieh@ntuh.gov.tw', 'phone': '(02)23123456', 'phoneExt': '2499'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Jung-Hsien Hsieh, MD', 'role': 'CONTACT', 'email': 'jhhsieh@ntuh.gov.tw', 'phone': '0972651800'}, {'name': 'Sung-Tsang Hsieh, PHD', 'role': 'CONTACT', 'email': 'shsieh@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '88182'}], 'overallOfficials': [{'name': 'Jung-Hsien Hsieh, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}