Pathology of Skin, Nerve and Vasculature in the Amputated Limb of Diabetes
NCT ID: NCT00840164
Last Updated: 2011-10-17
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
50 participants
OBSERVATIONAL
2009-02-28
2013-12-31
Brief Summary
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2. To diagnose small-fiber sensory neuropathy of the contralateral leg by investigating the skin intervention
3. To search for (1) mechanisms of amputation and (2) prevention measures for further amputation in the currently healthy-looking limb
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 . Intra-epidermal nerve fiber (IENF) density is reduced in patient with impaired glucose tolerance and clinically overt diabetes . 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 willl 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 . Underlying sural nerve and posterior tibial nerve will be also harvested for further ultra-structural study. The result will be compared to the control group which were recruited from a previously described cohort matched by gender and age.
Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
Role: PRINCIPAL_INVESTIGATOR
Plasty surgery department, National Taiwan University Hospital
Locations
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Plasty surgery department, National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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200812048R
Identifier Type: -
Identifier Source: org_study_id