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Clinical Trials/NCT03044340
NCT03044340CompletedNot Applicable

Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner

Fondation Hôpital Saint-Joseph2 sites in 1 country33 target enrollmentStarted: January 12, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
33
Locations
2
Primary Endpoint
Assessment of Chlorine ion production change

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

erythermalgia patient

Experimental

patient will be measured chlorine ions impedance with the SUDOSCAN and evaluation on pain du to temperature with the THERMOTEST

Intervention: impedance measurement and pain evaluation (Other)

Outcomes

Primary Outcomes

Assessment of Chlorine ion production change

Time Frame: Day1

patient will be measured the impedance of chlorinates ions by Sudoscan

Assessment of Temperature changing sensitivity

Time Frame: Day1

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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