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Clinical Trials/NCT04927832
NCT04927832
Completed
Not Applicable

Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes

Hôpital Européen Marseille1 site in 1 country139 target enrollmentJuly 6, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Systemic Autoimmune Pathologies
Sponsor
Hôpital Européen Marseille
Enrollment
139
Locations
1
Primary Endpoint
Percentage of patients presenting diagnosis of small fiber neuropathy in chronic pathologies and / or unexplained pain syndrome
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

Very few studies have evaluated the prevalence of small fiber neuropathy (SFN) during pathologies that may be responsible for small fibers damage.

SUDOSCAN is a new rapid (2 minutes), automated, reproducible and non-invasive technology to assess small fiber neuropathy by sweat function.

With quantitative and reproducible results, SUDOSCAN allows physicians to early detect and follow-up peripheral neuropathy to monitor disease progression and assess treatment efficacy for a better patient management.

SUDOSCAN® could allow the identification of SFN in painful patients apart from another pathology already diagnosed responsible for SFN.

The purpose of the study SUDOCU is to assess the prevalence of small fiber neuropathies (SFN) in patients with systemic autoimmune pathologies or unexplained pain syndrome.

Registry
clinicaltrials.gov
Start Date
July 6, 2017
End Date
February 23, 2023
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hôpital Européen Marseille
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient corresponding to one of the two following groups:
  • Systemic autoimmune pathology known to be complicated by small fiber neuropathies.
  • The following autoimmune pathologies will be included: Lupus, Sjogren, Scleroderma, Myositis, rheumatoid arthritis, Sarcoidosis, Vasculitis of small or medium vessels
  • No conditions known to be responsible at SFN, unexplained pain symptoms
  • Aged ≥ 18 years
  • Having given free and informed written consent

Exclusion Criteria

  • Chronic alcoholism
  • Unbalanced diabetes
  • Chemotherapies
  • Vitamins B12, B1, B6 deficiencies

Outcomes

Primary Outcomes

Percentage of patients presenting diagnosis of small fiber neuropathy in chronic pathologies and / or unexplained pain syndrome

Time Frame: 53 months

Study Sites (1)

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