Neuropathy Evaluation Using the Vibration of a Mobile Phone

NCT ID: NCT05928013

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-19

Study Completion Date

2024-05-07

Brief Summary

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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

Detailed Description

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Conditions

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Diabetic Foot

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Person With Diabetes

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.

Group Type EXPERIMENTAL

Neurothesiometer

Intervention Type DIAGNOSTIC_TEST

The 'gold standard' device for Vibration Perception Threshold testing

NERVE

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Neurothesiometer

The 'gold standard' device for Vibration Perception Threshold testing

Intervention Type DIAGNOSTIC_TEST

NERVE

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Dorset NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NERVE

Identifier Type: -

Identifier Source: org_study_id

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