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A Study to Evaluate the Performance of VibraTip® by Different Clinical Users

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ClinicalTrials.gov Identifier: NCT01878682
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Edward Jude, Tameside Hospital NHS Foundation Trust

Tracking Information
First Submitted Date June 8, 2013
First Posted Date June 17, 2013
Last Update Posted Date April 4, 2019
Actual Study Start Date February 6, 2014
Actual Primary Completion Date July 10, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 14, 2013)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Evaluate the Performance of VibraTip® by Different Clinical Users
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.
Brief 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. 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients will be recruited while attending Tameside Hospital NHS Foundation Trust Diabetes Clinic for a routine 12 month diabetes check up
Condition Diabetes
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 14, 2013)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date July 10, 2014
Actual Primary Completion Date July 10, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01878682
Other Study ID Numbers VibraTip® SSFHC/002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Edward Jude, Tameside Hospital NHS Foundation Trust
Study Sponsor Tameside Hospital NHS Foundation Trust
Collaborators Not Provided
Investigators
Principal Investigator: Edward Jude, MD Tameside Hospital NHS Foundation Trust
PRS Account Tameside Hospital NHS Foundation Trust
Verification Date April 2019