Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2011-08-31
2013-12-31
Brief Summary
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2. Compare the pathology of control nerve and nerve from amputated limb of diabetes
Detailed Description
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Peripheral 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.
For 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.
We 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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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harvest nerve
harvest nerve from cadaveric donor and patients receiving nerve graft operation
harvest nerve
harvest nerve from cadaveric donor and patients receiving nerve graft operation
Interventions
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harvest nerve
harvest nerve from cadaveric donor and patients receiving nerve graft operation
Eligibility Criteria
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Inclusion Criteria
* Patients receiving nerve graft operation
Exclusion Criteria
10 Years
90 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jung-Hsien Hsieh, MD
Role: STUDY_DIRECTOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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200912006R
Identifier Type: -
Identifier Source: org_study_id