NERVE: Neuropathy Evaluation Using the Vibration of a Mobile Phone

• Sponsor: University Hospitals Dorset NHS Foundation Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05928013
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 74.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot	Diagnostic Test: Neurothesiometer; Diagnostic Test: NERVE	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Neuropathy Evaluation Using the Vibration Function of a Mobile Phone - the NERVE Study
• Actual Study Start Date: Apr 19, 2023
• Anticipated Primary Completion Date: Aug 19, 2023
• Anticipated Study Completion Date: Aug 19, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Person With Diabetes 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.

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

Outcome Measures

Primary Outcome Measures

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

   Measured using Neurothesiometer and NERVE device

2. Vibration Perception Threshold (volts) as measured by Health Care Professionals [Follow up within baseline visit]

   Measured using Neurothesiometer and NERVE device

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

   Measured using NERVE device

4. Vibration Perception Threshold (volts) as measured by person with diabetes [Follow up within baseline visit]

   Measured using NERVE device

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Formally Diagnosed With Diabetes

Exclusion Criteria:

• 1. Un- willing or un-able to provide free informed consent (no time limit)
• 1. Un-willing or un-able to comply with all protocol requirements including study assessments;
• 1. Bilateral foot ulcers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Bournemouth Hospital	Bournemouth	Dorset	United Kingdom	BH7 7DW

Sponsors and Collaborators

• University Hospitals Dorset NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospitals Dorset NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT05928013
• Other Study ID Numbers: NERVE
• First Posted: Jul 3, 2023
• Last Update Posted: Jul 3, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetic Foot

Study Results

No Results Posted as of Jul 3, 2023