Status:
COMPLETED
Normative Data of Intra-epidermal Nerve Fiber Density
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Healthy
Eligibility:
All Genders
20-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01498211
Start Date
December 1 2011
End Date
May 1 2014
Last Update
December 22 2025
Active Locations (3)
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1
CHU de Besançon
Besançon, France, 25030
2
CHU de Nancy
Nancy, France, 54035
3
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091