Neuropathy Evaluation Using the Vibration of a Mobile Phone

Not Applicable

Completed

• Conditions: Diabetic Foot
• Interventions: Diagnostic Test: Neurothesiometer; Diagnostic Test: NERVE

• Registration Number: NCT05928013
• Lead Sponsor: University Hospitals Dorset NHS Foundation Trust

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-19
• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-07-03
• Primary Completion: 2024-05-07
• Study Completion: 2024-05-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Person With Diabetes	Neurothesiometer	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.
Person With Diabetes	NERVE	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.

Primary Outcome Measures

Name	Time	Method
Vibration Perception Threshold (volts) as measured by Health Care Professionals	Follow up within baseline visit	Measured using Neurothesiometer and NERVE device
Vibration Perception Threshold (volts) as measured by person with diabetes	Follow up within baseline visit	Measured using NERVE device

Trial Locations

Locations (1)

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, Dorset, United Kingdom