Neuropathy Evaluation Using the Vibration of a Mobile Phone (NERVE)

University Hospitals Dorset NHS Foundation Trust

Status: Completed

Conditions: Diabetic Foot

Treatments: Diagnostic Test: Neurothesiometer; Diagnostic Test: NERVE

Study type: Interventional

Funder types: Other

Identifiers

NCT05928013

NERVE

Details and patient eligibility

About

A single centre validation/method comparison study of the experimental NERVE device for the measurement of vibration perception threshold against the established 'Neurothesiometer' device, evaluating agreement and reliability. It will also include collecting feedback from patients, carers and clinicians on the usability of the device

Enrollment: 328 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Formally Diagnosed With Diabetes

Exclusion criteria

• 1. Un- willing or un-able to provide free informed consent (no time limit)
• 2. Un-willing or un-able to comply with all protocol requirements including study assessments;
• 3. Bilateral foot ulcers

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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328 participants in 1 patient group

Person With Diabetes

Experimental group

Description:

A health care professional will conduct the vibration perception threshold testing using both the Neurothesiometer and NERVE diagnostic testing on the person with diabetes. The person with diabetes will conduct the vibration perception threshold testing using the NERVE device. There is an option for a carer/buddy to conduct the vibration perception threshold testing with the NERVE device on the person with diabetes.

Treatment:

Diagnostic Test: NERVE

Diagnostic Test: Neurothesiometer