Vibratip Community Medical Practitioners Evaluation
Research type
Research Study
Full title
A study to evaluate the performance of the VibraTip® product by different community medical practitioners compared to an expert validation by a Diabetologists.
IRAS ID
93494
Contact name
Edward Jude
Contact email
Sponsor organisation
Tamside General Hospital
Research summary
VibraTip® is a pocket-sized, wipe-clean, disposable device that provides a consistent source of gentle vibration. 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.
This 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, validated by an expert Diabetologists.
The primary objective is to evaluate 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 secondary objectives are to evaluate the accuracy and usability of the VibraTip® device, as measured by different community medical practitioners compared to expert validation by a Diabetologist.
The study will aim to invite 180 patients to take part in the study, in an aim to recruit a minimum of 100 subjects. This is the number of patients which would need to be assessed by both the practitioners and the expert.
Patients will be recruited while attending Tameside Hospital NHS Foundation Trust Diabetes Clinic for a routine 12 month diabetes check up.
The dataset from the Expert Validation of the VibraTip will be compared against that of the 10g Semmes Weinstein Monofilament (MF) Test and the Tuning Fork test to see if the VibraTip is accurate.
The dataset from the community medical practitioners (Podiatrist & Practice Nurse) will be compared to that of the Expert Validation to see if the VibraTip can be used accurately by members of the community medical practitioners and user questionnaires, completed by the community medical practitioners, will be evaluated to ascertain usability.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0059
Date of REC Opinion
6 Jun 2013
REC opinion
Further Information Favourable Opinion