Normative Data of Intra-epidermal Nerve Fiber Density

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: NCT01498211
Recruitment Status : Unknown
Verified December 2011 by University Hospital, Strasbourg, France.
Recruitment status was:  Active, not recruiting
First Posted : December 23, 2011
Last Update Posted : July 6, 2012
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Procedure: Biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin
Study Start Date : December 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : June 2013

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: Biopsy Procedure: Biopsy
3 mm punch biopsy of the skin at the distal leg.

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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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): NCT01498211

CHU de Besançon
Besançon, France, 25030
CHU de Nancy
Nancy, France, 54035
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Nicolas COLLONGUES, MD University Hospital, Strasbourg, France

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT01498211     History of Changes
Other Study ID Numbers: 4961
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: December 2011

Keywords provided by University Hospital, Strasbourg, France: