Neuropathy Evaluation Using the Vibration of a Mobile Phone
NERVE
1 other identifier
interventional
328
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 19, 2023
CompletedFirst Submitted
Initial submission to the registry
May 25, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2024
CompletedFebruary 21, 2025
February 1, 2025
1.1 years
May 25, 2023
February 19, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Vibration Perception Threshold (volts) as measured by Health Care Professionals
Measured using Neurothesiometer and NERVE device
Baseline
Vibration Perception Threshold (volts) as measured by Health Care Professionals
Measured using Neurothesiometer and NERVE device
Follow up within baseline visit
Vibration Perception Threshold (volts) as measured by person with diabetes
Measured using NERVE device
Baseline
Vibration Perception Threshold (volts) as measured by person with diabetes
Measured using NERVE device
Follow up within baseline visit
Study Arms (1)
Person With Diabetes
EXPERIMENTALA 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.
Interventions
The 'gold standard' device for Vibration Perception Threshold testing
The experimental device for Vibration Perception Threshold testing developed by the project team
Eligibility Criteria
You may qualify if:
- Formally Diagnosed With Diabetes
You may not qualify if:
- \. Un- willing or un-able to provide free informed consent (no time limit)
- \. Un-willing or un-able to comply with all protocol requirements including study assessments;
- \. Bilateral foot ulcers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2023
First Posted
July 3, 2023
Study Start
April 19, 2023
Primary Completion
May 7, 2024
Study Completion
May 7, 2024
Last Updated
February 21, 2025
Record last verified: 2025-02