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Completed

NCT Number: NCT05928013

Neuropathy Evaluation Using the Vibration of a Mobile Phone

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

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurothesiometer

Diagnostic Test

The 'gold standard' device for Vibration Perception Threshold testing

NERVE

Diagnostic Test

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

Primary outcomes

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

    Time frame: Baseline

    Measured using Neurothesiometer and NERVE device

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

    Time frame: Follow up within baseline visit

    Measured using Neurothesiometer and NERVE device

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

    Time frame: Baseline

    Measured using NERVE device

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

    Time frame: Follow up within baseline visit

    Measured using NERVE device

Sponsors and collaborators

Lead sponsor

University Hospitals Dorset NHS Foundation Trust

Other Gov

Registry information

Official study title

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

Acronym: NERVE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2023
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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