Normative Data of Intra-epidermal Nerve Fiber Density

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University Hospital, Strasbourg, France.
Recruitment status was  Active, not recruiting
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
  Purpose

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 Intervention
Healthy
Procedure: Biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: December 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biopsy Procedure: Biopsy
3 mm punch biopsy of the skin at the distal leg.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01498211

Locations
France
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
Investigators
Principal Investigator: Nicolas COLLONGUES, MD University Hospital, Strasbourg, France
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01498211     History of Changes
Other Study ID Numbers: 4961
Study First Received: December 12, 2011
Last Updated: July 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
volunteer

ClinicalTrials.gov processed this record on October 19, 2014