DiabetesNCT01878682
A Study to Evaluate the Performance of VibraTip® by Different Clinical Users
An observational study of Diabetes, run by Tameside Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
VibraTip® is a pocket-sized, wipe-clean, disposable device that provides a consistent source of gentle vibration. It has been specifically designed to overcome the limitations of tuning forks for testing the integrity of vibration sense in clinic and by the bedside. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2014to 10 Jul 2014
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited while attending Tameside Hospital NHS Foundation Trust Diabetes Clinic for a routine 12 month diabetes check up
Who may be able to join
- Subjects aged 18 to 75 (inclusive) of either sex Subjects from whom consent has been obtained Subjects with pre-existing diabetes (Type 1 and Type 2)
Who cannot join
- Subjects unable to give consent
- Subjects aged less than 18 years or over 75 years
- Subjects with non-diabetic causes of neuropathy
- Subjects who have already taken part in the study
- Subjects who have active foot ulceration on the big toe
- Subjects who have PAD ABPI < 0.7
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Tameside Hospital NHS Foundation Trust
Ashton-under-Lyne, Lancs, OL69RW
About this study
Official title: A Study to Evaluate the Performance of the VibraTip® Product by Different Community Medical Practitioners Compared to an Expert Validation by a Diabetologists.
VibraTip® is a pocket-sized, wipe-clean, disposable device that provides a consistent source of gentle vibration. It has been specifically designed to overcome the limitations of tuning forks for testing the integrity of vibration sense in clinic and by the bedside. The product is a hand held device that is used to examine the feet of Diabetic patients who are susceptible to peripheral neuropathy that can in turn lead to ulcers. Treatment is expensive and can be over a period of time, often not being completely resolved, and can lead to amputation. The product will increase awareness of foot care and achieve a reduction in incidence of foot ulcers.
The study aims to evaluate the accuracy of the VibraTip device compared to the Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test, and the accuracy and usability of the VibraTip® device, as measured by different community medical practitioners.
Read the detailed description
Primary Objective The accuracy of the VibraTip® device, as measured by a comparison with the Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test by a Diabetologist.
Secondary Objectives The accuracy and usability of the VibraTip® device, as measured by different community medical practitioners compared to expert validation by a Diabetologist.
Prospective, single centre diagnostic evaluation. A single centre in the UK (Tameside Hospital NHS Foundation Trust). Patients will be recruited while attending Tameside Hospital NHS Foundation Trust Diabetes Clinic for a routine 12 month diabetes check up. Subjects will receive a Patient Letter to invite them to take part in the VibraTip study and a Patient Information Leaflet about the study enclosed within their Diabetes Clinic appointment. The study will aim to invite 180 patients to take part in the study and aims to recruit 100 subjects into the study within 3 months. Subjects aged 18 to 75 (inclusive) of either sex with pre-existing diabetes (Type 1 and Type 2). The study aims to recruit approximately 50 (50%) of patients with diabetic peripheral neuropathy (both painful and painless) and 50 (50%) without diabetic peripheral neuropathy. (we will go for even split if possible)
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of the VibraTip® device, as measured by a comparison with the Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test by a Diabetologist.
The accuracy of the VibraTip® device, as measured by a comparison with the Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test by a Diabetologist.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study start6 Feb 2014
- Primary completion10 Jul 2014
- Study completion10 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tameside Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Edward Jude, Tameside Hospital NHS Foundation Trust
- Investigators
- Edward Jude, MD, Principal investigator, Tameside Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878682
- Sponsor's protocol ID
- VibraTip® SSFHC/002
- Status last verified
- Apr 2019
- First submitted
- 8 Jun 2013
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Performance of the VibraTip® Product by Different Community Medical Practitioners Compared to an Expert Validation by a Diabetologists.
- ClinicalTrials.gov ID
- NCT01878682
- Acronym / sponsor ID
- VibraTip® SSFHC/002
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tameside Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Feb 2014 (actual)
- Primary completion
- 10 Jul 2014 (actual)
- Study completion
- 10 Jul 2014 (actual)
- First posted
- 17 Jun 2013 (estimated)
- 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.
VibraTip® is a pocket-sized, wipe-clean, disposable device that provides a consistent source of gentle vibration. It has been specifically designed to overcome the limitations of tuning forks for testing the integrity of vibration sense in clinic and by the bedside. The product is a hand held device that is used to examine the feet of Diabetic patients who are susceptible to peripheral neuropathy that can in turn lead to ulcers. Treatment is expensive and can be over a period of time, often not being completely resolved, and can lead to amputation. The product will increase awareness of foot care and achieve a reduction in incidence of foot ulcers.
The study aims to evaluate the accuracy of the VibraTip device compared to the Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test, and the accuracy and usability of the VibraTip® device, as measured by different community medical practitioners.
Detailed description
Primary Objective The accuracy of the VibraTip® device, as measured by a comparison with the Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test by a Diabetologist.
Secondary Objectives The accuracy and usability of the VibraTip® device, as measured by different community medical practitioners compared to expert validation by a Diabetologist.
Prospective, single centre diagnostic evaluation. A single centre in the UK (Tameside Hospital NHS Foundation Trust). Patients will be recruited while attending Tameside Hospital NHS Foundation Trust Diabetes Clinic for a routine 12 month diabetes check up. Subjects will receive a Patient Letter to invite them to take part in the VibraTip study and a Patient Information Leaflet about the study enclosed within their Diabetes Clinic appointment. The study will aim to invite 180 patients to take part in the study and aims to recruit 100 subjects into the study within 3 months. Subjects aged 18 to 75 (inclusive) of either sex with pre-existing diabetes (Type 1 and Type 2). The study aims to recruit approximately 50 (50%) of patients with diabetic peripheral neuropathy (both painful and painless) and 50 (50%) without diabetic peripheral neuropathy. (we will go for even split if possible)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited while attending Tameside Hospital NHS Foundation Trust Diabetes Clinic for a routine 12 month diabetes check up
Key inclusion criteria (1 listed)
- Subjects aged 18 to 75 (inclusive) of either sex Subjects from whom consent has been obtained Subjects with pre-existing diabetes (Type 1 and Type 2)
Key exclusion criteria (6 listed)
- Subjects unable to give consent
- Subjects aged less than 18 years or over 75 years
- Subjects with non-diabetic causes of neuropathy
- Subjects who have already taken part in the study
- Subjects who have active foot ulceration on the big toe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The accuracy of the VibraTip® device, as measured by a comparison with the Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test by a Diabetologist.
Time frame: 3 months
The accuracy of the VibraTip® device, as measured by a comparison with the Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test by a Diabetologist.
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 4 Apr 2019.
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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.
Edward Jude, MD principal investigator
Tameside Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Tameside Hospital 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 6 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 4 Apr 2019. 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?
The accuracy of the VibraTip® device, as measured by a comparison with the Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test by a Diabetologist. (time frame: 3 months). 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 4 Apr 2019.