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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05928013
Other study ID # NERVE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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