Overview

This trial is active, not recruiting.

Condition healthy
Treatment biopsy
Sponsor University Hospital, Strasbourg, France
Start date December 2011
End date December 2012
Trial size 300 participants
Trial identifier NCT01498211, 4961

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
biopsy
3 mm punch biopsy of the skin at the distal leg.

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin
Principal investigator Nicolas COLLONGUES, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by University Hospital, Strasbourg, France.