Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale (WISUDO)

Withings

Status

Completed

Conditions

Neuropathy

Treatments

Diagnostic Test: Neuropathy measurement

Study type

Observational

Funder types

Industry

Identifiers

NCT05178459

2021-A02624-37

Details and patient eligibility

About

The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.

Full description

Patients with neuropathy are included in hospitals. Each patient will have his neuropathy evaluated with Withings WBS08 and its reference the Sudoscan.

Enrollment

177 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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
- 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