Status:
COMPLETED
A Study to Evaluate the Performance of VibraTip® by Different Clinical Users
Lead Sponsor:
Tameside Hospital NHS Foundation Trust
Conditions:
Diabetes
Eligibility:
All Genders
18-75 years
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 test...
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 Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 6 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 10 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01878682
Start Date
February 6 2014
End Date
July 10 2014
Last Update
April 4 2019
Active Locations (1)
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1
Tameside Hospital NHS Foundation Trust
Ashton-under-Lyne, Lancs, United Kingdom, OL69RW