Diabetic FootNERVENCT05928013
Neuropathy Evaluation Using the Vibration of a Mobile Phone
A study testing Neurothesiometer and NERVE in people with Diabetic Foot, run by University Hospitals Dorset NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Neurothesiometer and NERVE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Apr 2023to 7 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Formally Diagnosed With Diabetes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
About this study
Official title: Neuropathy Evaluation Using the Vibration Function of a Mobile Phone - the NERVE Study
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
- Conditions
- Diabetic Foot
- Being tested
- Neurothesiometer, NERVE
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurothesiometerDiagnostic test
The 'gold standard' device for Vibration Perception Threshold testing
NERVEDiagnostic test
The experimental device for Vibration Perception Threshold testing developed by the project team
| Study group | Role | What they receive |
|---|---|---|
| Person With Diabetes | Experimental | 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. Receives: Diagnostic Test: Neurothesiometer; Diagnostic Test: NERVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vibration Perception Threshold (volts) as measured by Health Care Professionals
Measured using Neurothesiometer and NERVE device
Measured: Baseline
Vibration Perception Threshold (volts) as measured by Health Care Professionals
Measured using Neurothesiometer and NERVE device
Measured: Follow up within baseline visit
Vibration Perception Threshold (volts) as measured by person with diabetes
Measured using NERVE device
Measured: Baseline
Vibration Perception Threshold (volts) as measured by person with diabetes
Measured using NERVE device
Measured: Follow up within baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start19 Apr 2023
- Primary completion7 May 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Dorset NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928013
- Sponsor's protocol ID
- NERVE
- Acronym
- NERVE
- Status last verified
- Feb 2025
- First submitted
- 25 May 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathy Evaluation Using the Vibration Function of a Mobile Phone - the NERVE Study
- ClinicalTrials.gov ID
- NCT05928013
- Acronym / sponsor ID
- NERVE / NERVE
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- University Hospitals Dorset NHS Foundation TrustOther government
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Person With Diabetes | Experimental | Diagnostic Test: Neurothesiometer, Diagnostic Test: NERVEA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Formally Diagnosed With Diabetes
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurothesiometerThe 'gold standard' device for Vibration Perception Threshold testing | Diagnostic test | Person With Diabetes |
| NERVEThe experimental device for Vibration Perception Threshold testing developed by the project team | Diagnostic test | Person With Diabetes |
Primary outcome
Vibration Perception Threshold (volts) as measured by Health Care Professionals
Time frame: Baseline
Measured using Neurothesiometer and NERVE device
Vibration Perception Threshold (volts) as measured by Health Care Professionals
Time frame: Follow up within baseline visit
Measured using Neurothesiometer and NERVE device
Vibration Perception Threshold (volts) as measured by person with diabetes
Time frame: Baseline
Measured using NERVE device
Vibration Perception Threshold (volts) as measured by person with diabetes
Time frame: Follow up within baseline visit
Measured using NERVE device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Foot
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Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurothesiometer and NERVE in people with Diabetic Foot, run by University Hospitals Dorset NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vibration Perception Threshold (volts) as measured by Health Care Professionals (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.