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Normative Data of Intra-epidermal Nerve Fiber Density

NCT ID: NCT01498211

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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volunteer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Biopsy

Group Type EXPERIMENTAL

Biopsy

Intervention Type PROCEDURE

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

Interventions

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Biopsy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas COLLONGUES, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Strasbourg, France

Locations

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CHU de Besançon

Besançon, , France

Site Status

CHU de Nancy

Nancy, , France

Site Status

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 29370274 (View on PubMed)

Other Identifiers

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4961

Identifier Type: -

Identifier Source: org_study_id