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Completed

NCT Number: NCT01498211

Normative Data of Intra-epidermal Nerve Fiber Density

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.

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Key information

Conditions

Healthy

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy

Procedure

3 mm punch biopsy of the skin at the distal leg.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Dec 23, 2011
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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