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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: Biopsy

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • CHU de Besançon
  • Nancy, France, 54035
    • CHU de NANCY
  • Strasbourg, France, 67091
    • Hopitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biopsy	Procedure: Biopsy; 3 mm punch biopsy of the skin at the distal leg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure density of intraepidermic nervous fibres by optical and electronic microscopy in a population of healthy witnesses according to the age and the sex.	1 month

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Nicolas COLLONGUES, MD, University Hospital, Strasbourg, france

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: December 12, 2011
• First Submitted That Met QC Criteria: December 20, 2011
• First Posted (Estimated): December 23, 2011

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: volunteer
• Additional Relevant MeSH Terms: Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Biopsy
• Other Study ID Numbers: 4961