Normative Data of Intra-epidermal Nerve Fiber Density

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Procedure: Biopsy

• Registration Number: NCT01498211
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-12
• Study Start: 2011-12
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-23
• Primary Completion: 2012-12
• Study Completion: 2014-05
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biopsy	Biopsy	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

CHU de Nancy; 🇫🇷 Nancy, France

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Besançon; 🇫🇷 Besançon, France