NeuropathyWISUDONCT05178459
Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale
An observational study of Neuropathy, run by Withings at 4 sites in France.
Trial summary
The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy
- What is being tested?
- Neuropathy measurement
- How many people
- 177 participants
- Where
- 4 sitesFrance
- Study dates
- 11 Mar 2022to 8 Aug 2022
- Phase
- Observational
- 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
Study population: In and out patients from endocrinology and neuropathy departments
Who may be able to join
- The subject is an adult, man or woman (18 years old or more)
- Subjects affiliated or eligible to a social security system
- Subjects having expressed their consent to take part in the study
- Two type of patients are included in the study :
- Patients having diabetes (80% of the inclusion)
- Non diabetic patients having a lower limbs neuropathy (20% of the inclusion)
Who cannot join
- Minors under 18 years old
- Subject is pregnant or trying to get pregnant
- Subjects having a pacemaker
- Subjects having refused to give their consent
- Vulnerable subjects according to the French regulation in force:
- Individuals deprived of liberty by a court, medical or administrative order
Show all 13Show fewer
- Individuals legally protected or unable to express their consent to take part in the study
- Individuals unaffiliated to or not beneficiary of a social security system
- Individuals who fit in multiple categories above
- Individuals linguistically or mentally unable to express their consent
- Individuals having an lower limb amputation bigger than toes
- Individuals not able to stand still for a few minutes
- Individuals under antidepressant medications
Trial locations and contacts
4 sites in 1 country.
France4 sites
Henri-Mondor Hospital
Créteil, Île-de-France Region, 94000
Lariboisière Hospital
Paris, Île-de-France Region, 75010
Cochin Hospital
Paris, Île-de-France Region, 75014
Bichat-Claude Bernard Hospital
Paris, Île-de-France Region, 75018
About this study
The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.
Read the detailed description
Patients with neuropathy are included in hospitals. Each patient will have his neuropathy evaluated with Withings WBS08 and its reference the Sudoscan.
- Conditions
- Neuropathy
- Being tested
- Neuropathy measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropathy measurementDiagnostic test
Patient will step on Withings WBS08 and on the Sudoscan to get their sudomotor dysfunction caused by the neuropathy evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic | Patient diagnosed with diabetes Receives: Diagnostic Test: Neuropathy measurement | |
| Neuropathic without diabetes | Patient diagnosed with neuropathy without diabetes Receives: Diagnostic Test: Neuropathy measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sudomotor dysfunction diagnostic performance evaluation
The diagnostic performance of the Withings WBS08 will be established using the sensitivity and the specificity for an electrochemical skin conductance threshold (moderate dysfunction and severe dysfunction).
Measured: 10 months
Secondary outcomes (3)
Evaluate the accuracy of Withings WBS08 to measure the sudomotor function on each foot and by averaging the value on both feet.
The root-mean-square error (RMSE) and the mean absolute error (MAE) between the sudomotor function value measured by the Withings WBS08 and the Sudoscan as reference on each foot and by averagin g both feet.
Measured: 10 months
Compare the diagnostic of Withings WBS08 to diabetes neuropathy questionnaires
The correlation between diabetes neuropathy questionnair es and Withings WBS08.
Measured: 10 months
Safety use of this device
The rate of adverse effects.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start11 Mar 2022
- Primary completion22 Jul 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuropathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louis Potier, Dr, Principal investigator, Bichat-Claude Bernard Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178459
- Sponsor's protocol ID
- 2021-A02624-37
- Acronym
- WISUDO
- Status last verified
- Jan 2023
- First submitted
- 15 Dec 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riveline JP, Mallone R, Tiercelin C, Yaker F, Alexandre-Heymann L, Khelifaoui L, Travert F, Fertichon C, Julla JB, Vidal-Trecan T, Potier L, Gautier JF, Larger E, Lefaucheur JP. Validation of the Body Scan(R), a new device to detect small fiber neuropathy by assessment of the sudomotor function: agreement with the Sudoscan(R). Front Neurol. 2023 Oct 31;14:1256984. doi: 10.3389/fneur.2023.1256984. eCollection 2023.
PubMed 38020587
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale
- ClinicalTrials.gov ID
- NCT05178459
- Acronym / sponsor ID
- WISUDO / 2021-A02624-37
- Conditions
- Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 5 Jan 2022 (actual)
- 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.
The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.
Detailed description
Patients with neuropathy are included in hospitals. Each patient will have his neuropathy evaluated with Withings WBS08 and its reference the Sudoscan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic | – | Diagnostic Test: Neuropathy measurementPatient diagnosed with diabetes |
| Neuropathic without diabetes | – | Diagnostic Test: Neuropathy measurementPatient diagnosed with neuropathy without diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In and out patients from endocrinology and neuropathy departments
Key inclusion criteria (6 listed)
- The subject is an adult, man or woman (18 years old or more)
- Subjects affiliated or eligible to a social security system
- Subjects having expressed their consent to take part in the study
- Two type of patients are included in the study :
Key exclusion criteria (13 listed)
- Minors under 18 years old
- Subject is pregnant or trying to get pregnant
- Subjects having a pacemaker
- Subjects having refused to give their consent
- Vulnerable subjects according to the French regulation in force:
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 |
|---|---|---|
| Neuropathy measurementPatient will step on Withings WBS08 and on the Sudoscan to get their sudomotor dysfunction caused by the neuropathy evaluated. | Diagnostic test | Diabetic, Neuropathic without diabetes |
Primary outcome
Sudomotor dysfunction diagnostic performance evaluation
Time frame: 10 months
The diagnostic performance of the Withings WBS08 will be established using the sensitivity and the specificity for an electrochemical skin conductance threshold (moderate dysfunction and severe dysfunction).
3 secondary outcomes
Evaluate the accuracy of Withings WBS08 to measure the sudomotor function on each foot and by averaging the value on both feet.
Time frame: 10 months
Compare the diagnostic of Withings WBS08 to diabetes neuropathy questionnaires
Time frame: 10 months
Safety use of this device
Time frame: 10 months
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 Jan 2023.
- Derived from this study: PubMed 38020587Riveline JP, Mallone R, Tiercelin C, Yaker F, Alexandre-Heymann L, Khelifaoui L, Travert F, Fertichon C, Julla JB, Vidal-Trecan T, Potier L, Gautier JF, Larger E, Lefaucheur JP. Validation of the Body Scan(R), a new device to detect small fiber neuropathy by assessment of the sudomotor function: agreement with the Sudoscan(R). Front Neurol. 2023 Oct 31;14:1256984. doi: 10.3389/fneur.2023.1256984. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Louis Potier, Dr principal investigator
Bichat-Claude Bernard Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathy, run by Withings at 4 sites 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 6 inclusion and 13 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 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Sudomotor dysfunction diagnostic performance evaluation (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05178459, which also lists 1 linked publication.
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 Jan 2023.