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OpenTrials
Completed

NCT Number: NCT03044340

Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner and QST

Erythromelalgy (EM) is a vascular syndrome very rare affecting the feet. This disease evolve by crisis when the feet extremities become red hot and painful. There are several types of EM but this study concern the adult primitive form. For a long time, the physiopathology was not described but now we know that there is a vascular form, with microcirculatory dysfunction and a neurologic form with small fibers neuropathy. The diagnostic of neurologic form is based on clinical evaluation (DN4 questionnaire, UENS scale...) and an electromyography. Thermotest, a medical device which measure the thermic sensitivity is used to quantify neuropathy. More recently Sudoscan, a device measuring cutaneous impedance to chloride ions detect small nervous fiber in diabetic patients with good correlation with Thermotest.

The purpose of this study is to analyze the vascular side and the neurologic side on patients consulting for Erythromelalgy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pain with burn feeling at hands and feet extremities
  • Crisis activated by the heat
  • Age > 18 years old

Exclusion criteria

  • Patients who had burn in extremities

Treatment and study plan

impedance measurement and pain evaluation

Other

Measurement of chlorine ions impedance by SUDOSCAN and pain due to temperature evaluation with THERMOTEST

Primary outcomes

  1. Assessment of Chlorine ion production change

    Time frame: Day1

    patient will be measured the impedance of chlorinates ions by Sudoscan

  2. Assessment of Temperature changing sensitivity

    Time frame: Day1

    Patients will be measured their sensitivity to temperature changing using the Thermotest

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Official study title

Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 7, 2017
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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