Back to resultsNeuropathy Evaluation Using the Vibration of a Mobile Phone (NERVE)
Primary Purpose
Diabetic Foot
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Neurothesiometer
NERVE
Sponsored by
About this trial
This is an interventional screening trial for Diabetic Foot
Eligibility Criteria
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
Sites / Locations
- Royal Bournemouth HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Person With Diabetes
Arm Description
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.
Outcomes
Primary Outcome Measures
Vibration Perception Threshold (volts) as measured by Health Care Professionals
Measured using Neurothesiometer and NERVE device
Vibration Perception Threshold (volts) as measured by Health Care Professionals
Measured using Neurothesiometer and NERVE device
Vibration Perception Threshold (volts) as measured by person with diabetes
Measured using NERVE device
Vibration Perception Threshold (volts) as measured by person with diabetes
Measured using NERVE device
Secondary Outcome Measures
Full Information
NCT ID
NCT05928013
First Posted
May 25, 2023
Last Updated
June 28, 2023
Sponsor
University Hospitals Dorset NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05928013
Brief Title
Neuropathy Evaluation Using the Vibration of a Mobile Phone
Acronym
NERVE
Official Title
Neuropathy Evaluation Using the Vibration Function of a Mobile Phone - the NERVE Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
August 19, 2023 (Anticipated)
Study Completion Date
August 19, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Dorset NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Person With Diabetes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Neurothesiometer
Intervention Description
The 'gold standard' device for Vibration Perception Threshold testing
Intervention Type
Diagnostic Test
Intervention Name(s)
NERVE
Intervention Description
The experimental device for Vibration Perception Threshold testing developed by the project team
Primary Outcome Measure Information:
Title
Vibration Perception Threshold (volts) as measured by Health Care Professionals
Description
Measured using Neurothesiometer and NERVE device
Time Frame
Baseline
Title
Vibration Perception Threshold (volts) as measured by Health Care Professionals
Description
Measured using Neurothesiometer and NERVE device
Time Frame
Follow up within baseline visit
Title
Vibration Perception Threshold (volts) as measured by person with diabetes
Description
Measured using NERVE device
Time Frame
Baseline
Title
Vibration Perception Threshold (volts) as measured by person with diabetes
Description
Measured using NERVE device
Time Frame
Follow up within baseline visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Savage
Phone
0300 019 2025
Email
sarah.savage@uhd.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
NERVE The Nerve Study
Phone
0300 019 2025
Ext
2025
Email
thenervestudy@uhd.nhs.uk
Facility Information:
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Office
Email
researchoffice@uhd.nhs.uk
First Name & Middle Initial & Last Name & Degree
Debbie Sharman
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Neuropathy Evaluation Using the Vibration of a Mobile Phone
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