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Normative Data of Intra-epidermal Nerve Fiber Density

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01498211
First received: December 12, 2011
Last updated: July 4, 2012
Last verified: December 2011
History of Changes

December 12, 2011
July 4, 2012
December 2011
December 2012   (final data collection date for primary outcome measure)
Measure density of intraepidermic nervous fibres by optical and electronic microscopy in a population of healthy witnesses according to the age and the sex. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01498211 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Normative Data of Intra-epidermal Nerve Fiber Density
Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin

Intra-epidermal nerve fiber density can be assessed using skin biopsy. A decrease of this density is used to diagnose small fiber neuropathy, despite the absence of normative data in a selected normal population. To establish a normative set of data matched for age and sex is absolutely needed to evaluate the sensibility and specificity of this test.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Healthy
Procedure: Biopsy
3 mm punch biopsy of the skin at the distal leg.
Experimental: Biopsy
Intervention: Procedure: Biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
June 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Man or woman between 20-80 years old
  • Normal subjects without pain and neurological impairment
  • No history of neurological disorder
  • Normal neurological examination
  • Normal ECG
  • Normal clotting sample from less than 6 months
  • Available by phone

Exclusion criteria :

  • History of alcoholic intoxication or chemotherapy
  • History of diabetes, kidney insufficiency, monoclonal gammapathy, B/C hepatitis, HIV, coeliac disease, sicca syndrome, raynaud syndrome, systemic erythematous lupus, Fabry disease, amylosis, vascularitis
  • Contraindication to xylocaïn with adrenalin
  • At the site of biopsy : surgery, skin pathology, infection, vascular insufficiency
  • Innate or acquired immunosuppression
  • Innate or acquired clotting abnormality
Both
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01498211
4961
No
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Principal Investigator: Nicolas COLLONGUES, MD University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP