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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044340
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Erythermalgia Other: impedance measurement and pain evaluation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner
Actual Study Start Date : January 12, 2017
Actual Primary Completion Date : January 18, 2018
Actual Study Completion Date : April 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: erythermalgia patient
patient will be measured chlorine ions impedance with the SUDOSCAN and evaluation on pain du to temperature with the THERMOTEST
Other: impedance measurement and pain evaluation
Measurement of chlorine ions impedance by SUDOSCAN and pain due to temperature evaluation with THERMOTEST




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044340


Locations
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France
Groupe Hospitalier Paris Saint Joseph
Paris, Ile-de-France, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03044340    
Other Study ID Numbers: ERYTHROMELALGY
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erythromelalgia
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases