Anatomy Study in Control Nerve From Normal Human

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01052805
First received: January 18, 2010
Last updated: October 20, 2011
Last verified: October 2011
  Purpose
  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 Intervention
Anatomy of Normal Human Nerves
Microscopic Study
Myelinated Nerve and Unmyelinated Nerve Study
Procedure: harvest nerve

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Anatomy Study in Control Nerve From Normal Human

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Description:

nerve from cadaveric donor nerve from nerve graft operation patient


Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

cadaveric donor patients receiving nerve graft operation

Criteria

Inclusion Criteria:

  • Cadaveric donor
  • Patients receiving nerve graft operation

Exclusion Criteria:

  • Patient with neurologic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052805

Contacts
Contact: Jung-Hsien Hsieh, MD 0972651800 jhhsieh@ntuh.gov.tw
Contact: Sung-Tsang Hsieh, PHD 886-2-23123456 ext 88182 shsieh@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jung-Hsien Hsieh    (02)23123456 ext 2499    jhhsieh@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Jung-Hsien Hsieh, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01052805     History of Changes
Other Study ID Numbers: 200912006R
Study First Received: January 18, 2010
Last Updated: October 20, 2011
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on July 20, 2014