Anatomy Study in Control Nerve From Normal Human

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01052805
Recruitment Status : Unknown
Verified October 2011 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : January 20, 2010
Last Update Posted : October 21, 2011
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
  1. To explore the pathology of nerve, vasculature in the normal control nerve
  2. Compare the pathology of control nerve and nerve from amputated limb of diabetes

Condition or disease Intervention/treatment
Anatomy of Normal Human Nerves Microscopic Study Myelinated Nerve and Unmyelinated Nerve Study Procedure: harvest nerve

Detailed Description:

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.

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.

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Anatomy Study in Control Nerve From Normal Human
Study Start Date : August 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy
U.S. FDA Resources

Group/Cohort Intervention/treatment
harvest nerve
harvest nerve from cadaveric donor and patients receiving nerve graft operation
Procedure: harvest nerve
harvest nerve from cadaveric donor and patients receiving nerve graft operation

Biospecimen Description:
nerve from cadaveric donor nerve from nerve graft operation patient

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cadaveric donor patients receiving nerve graft operation

Inclusion Criteria:

  • Cadaveric donor
  • Patients receiving nerve graft operation

Exclusion Criteria:

  • Patient with neurologic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01052805

Contact: Jung-Hsien Hsieh, MD 0972651800
Contact: Sung-Tsang Hsieh, PHD 886-2-23123456 ext 88182

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jung-Hsien Hsieh    (02)23123456 ext 2499   
Sponsors and Collaborators
National Taiwan University Hospital
Study Director: Jung-Hsien Hsieh, MD National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital Identifier: NCT01052805     History of Changes
Other Study ID Numbers: 200912006R
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: October 21, 2011
Last Verified: October 2011

Keywords provided by National Taiwan University Hospital:
myelinated nerve
unmyelinated nerve