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Healthy volunteers needed to set nerve norms for better diagnosis

NCT ID NCT01498211

Knowledge-focused Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to establish normal values for nerve fiber density in the skin using small biopsies from 300 healthy adults aged 20-80. By comparing results across age and sex, researchers hope to improve the accuracy of diagnosing small fiber neuropathy, a condition that affects small nerves. Participants undergo a single 3mm skin punch biopsy from the lower leg.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide doctors with a standard reference to better diagnose small fiber neuropathy.
What could go wrong
This is an observational study, not a treatment trial. It only establishes normal values and may not directly improve patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

300 people

The number who actually took part.

Start date

Dec 2011

Finished

May 2014

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

Contacts and locations

Locations

  • CHU de Besançon

    Besançon, 25030, France

  • CHU de Nancy

    Nancy, 54035, France

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091, France

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