CClinicalTrials.gg
Sign In
CompletedNCT01498211Updated Dec 22, 2025

Normative Data of Intra-epidermal Nerve Fiber Density

An interventional study of Biopsy in Healthy, sponsored by University Hospital, Strasbourg, France. Completed at 3 sites in France. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • volunteer
03

In context

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 968 studies on the registry; 344 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Biopsy

    Procedure: Biopsy

Interventions

  • ProcedureBiopsy

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

06

What researchers measure

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

07

Study locations

3 sites
  • CHU de Besançon
    Besançon, 25030, France
  • CHU de Nancy
    Nancy, 54035, France
  • Hôpitaux Universitaires de Strasbourg
    Strasbourg, 67091, France
08

References and documents

Publications

  • Collongues N, Samama B, Schmidt-Mutter C, Chamard-Witkowski L, Debouverie M, Chanson JB, Antal MC, Benardais K, de Seze J, Velten M, Boehm N. Quantitative and qualitative normative dataset for intraepidermal nerve fibers using skin biopsy. PLoS One. 2018 Jan 25;13(1):e0191614. doi: 10.1371/journal.pone.0191614. eCollection 2018. PubMed 29370274 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01498211
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Dec 23, 2011
Start date
Dec 2011
Primary completion
Dec 2012
Completion
May 2014
Last update
Dec 22, 2025

Study contacts

Nicolas COLLONGUES, MD
principal investigator · University Hospital, Strasbourg, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University Hospital, Strasbourg, France

Start the discussion