Normative Data of Intra-epidermal Nerve Fiber Density
Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin
1 other identifier
interventional
300
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Dec 2011
Longer than P75 for not_applicable healthy
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 12, 2011
CompletedFirst Posted
Study publicly available on registry
December 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedDecember 22, 2025
December 1, 2025
1 year
December 12, 2011
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Biopsy
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
CHU de Besançon
Besançon, 25030, France
CHU de Nancy
Nancy, 54035, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
Related Publications (1)
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.
PMID: 29370274RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas COLLONGUES, MD
University Hospital, Strasbourg, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2011
First Posted
December 23, 2011
Study Start
December 1, 2011
Primary Completion
December 1, 2012
Study Completion
May 1, 2014
Last Updated
December 22, 2025
Record last verified: 2025-12