ErythermalgiaNCT03044340
Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner and QST
A study testing impedance measurement and pain evaluation in people with Erythermalgia, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythermalgia
- What is being tested?
- impedance measurement and pain evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2017to 17 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain with burn feeling at hands and feet extremities
- Crisis activated by the heat
- Age > 18 years old
Who cannot join
- Patients who had burn in extremities
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner
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.
- Conditions
- Erythermalgia
- Being tested
- impedance measurement and pain evaluation
- Medical subject headings
- Erythromelalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impedance measurement and pain evaluationOther
Measurement of chlorine ions impedance by SUDOSCAN and pain due to temperature evaluation with THERMOTEST
| Study group | Role | What they receive |
|---|---|---|
| erythermalgia patient | Experimental | patient will be measured chlorine ions impedance with the SUDOSCAN and evaluation on pain du to temperature with the THERMOTEST Receives: Other: impedance measurement and pain evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Chlorine ion production change
patient will be measured the impedance of chlorinates ions by Sudoscan
Measured: Day1
Assessment of Temperature changing sensitivity
Patients will be measured their sensitivity to temperature changing using the Thermotest
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start12 Jan 2017
- Primary completion18 Jan 2018
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythermalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044340
- Sponsor's protocol ID
- ERYTHROMELALGY
- Status last verified
- Apr 2019
- First submitted
- 31 Jan 2017
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular and Neurologic Exploration of Small Nervous Fiber by Sudoscanner
- ClinicalTrials.gov ID
- NCT03044340
- Acronym / sponsor ID
- ERYTHROMELALGY
- Conditions
- Erythermalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| erythermalgia patient | Experimental | Other: impedance measurement and pain evaluationpatient will be measured chlorine ions impedance with the SUDOSCAN and evaluation on pain du to temperature with the THERMOTEST |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pain with burn feeling at hands and feet extremities
- Crisis activated by the heat
- Age > 18 years old
Key exclusion criteria (1 listed)
- Patients who had burn in extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| impedance measurement and pain evaluationMeasurement of chlorine ions impedance by SUDOSCAN and pain due to temperature evaluation with THERMOTEST | Other | erythermalgia patient |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Erythermalgia
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
Active, not recruiting
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Erythromelalgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing impedance measurement and pain evaluation in people with Erythermalgia, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Chlorine ion production change (time frame: Day1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.