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

November 28, 2023 updated by: University Hospitals Dorset NHS Foundation Trust

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • Recruiting
        • Royal Bournemouth Hospital
        • Contact:
        • Principal Investigator:
          • Debbie Sharman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: Neurothesiometer
The 'gold standard' device for Vibration Perception Threshold testing
Diagnostic test: NERVE
The experimental device for Vibration Perception Threshold testing developed by the project team

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vibration Perception Threshold (volts) as measured by Health Care Professionals
Time Frame: Baseline
Measured using Neurothesiometer and NERVE device
Baseline
Vibration Perception Threshold (volts) as measured by Health Care Professionals
Time Frame: Follow up within baseline visit
Measured using Neurothesiometer and NERVE device
Follow up within baseline visit
Vibration Perception Threshold (volts) as measured by person with diabetes
Time Frame: Baseline
Measured using NERVE device
Baseline
Vibration Perception Threshold (volts) as measured by person with diabetes
Time Frame: Follow up within baseline visit
Measured using NERVE device
Follow up within baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Dorset NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NERVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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