Neuropathy Evaluation Using the Vibration of a Mobile Phone

Neuropathy Evaluation Using the Vibration Function of a Mobile Phone - the NERVE Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05928013

Acronym

NERVE

Enrollment

328

Registered

2023-07-03

Start date

2023-04-19

Completion date

2024-05-07

Last updated

2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

Brief summary

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

Interventions

DIAGNOSTIC_TESTNeurothesiometer

The 'gold standard' device for Vibration Perception Threshold testing

DIAGNOSTIC_TESTNERVE

The experimental device for Vibration Perception Threshold testing developed by the project team

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Vibration Perception Threshold (volts) as measured by Health Care Professionals	Baseline	Measured using Neurothesiometer and NERVE device
Vibration Perception Threshold (volts) as measured by person with diabetes	Baseline	Measured using NERVE device

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026