Neuropathy Evaluation Using the Vibration of a Mobile Phone

Diabetic Foot Clinical Trial

— NERVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928013
• Other study ID #: NERVE
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2023
• Source: University Hospitals Dorset NHS Foundation Trust
• Contact: Sarah Savage
• Phone: 0300 019 2025
• Email: sarah.savage[@]uhd.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Diagnostic Test:
• Neurothesiometer
The 'gold standard' device for Vibration Perception Threshold testing
• NERVE
The experimental device for Vibration Perception Threshold testing developed by the project team

Locations

Country	Name	City	State
United Kingdom	Royal Bournemouth Hospital	Bournemouth	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Dorset NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vibration Perception Threshold (volts) as measured by Health Care Professionals	Measured using Neurothesiometer and NERVE device	Baseline
Primary	Vibration Perception Threshold (volts) as measured by Health Care Professionals	Measured using Neurothesiometer and NERVE device	Follow up within baseline visit
Primary	Vibration Perception Threshold (volts) as measured by person with diabetes	Measured using NERVE device	Baseline
Primary	Vibration Perception Threshold (volts) as measured by person with diabetes	Measured using NERVE device	Follow up within baseline visit