Neuropathy Evaluation Using the Vibration of a Mobile Phone

University Hospitals Dorset NHS Foundation Trust328 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

328

Conditions

Diabetic Foot

Interventions

NeurothesiometerDIAGNOSTIC_TEST

The 'gold standard' device for Vibration Perception Threshold testing

NERVEDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom

Outcomes

Primary Outcomes

Vibration Perception Threshold (volts) as measured by Health Care Professionals

Measured using Neurothesiometer and NERVE device

Time frame: Baseline

Vibration Perception Threshold (volts) as measured by Health Care Professionals

Measured using Neurothesiometer and NERVE device

Time frame: Follow up within baseline visit

Vibration Perception Threshold (volts) as measured by person with diabetes

Measured using NERVE device

Time frame: Baseline

Vibration Perception Threshold (volts) as measured by person with diabetes

Measured using NERVE device

Time frame: Follow up within baseline visit

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.