VibraTip for the diagnosis of diabetic peripheral neuropathy
Research type
Research Study
Full title
NICE allocated work package: Prospective cohort study into VibraTip for the diagnosis of diabetic peripheral neuropathy
IRAS ID
183151
Contact name
Keith Brennan
Contact email
Sponsor organisation
King's College, London
Duration of Study in the UK
1 years, 11 months, 26 days
Research summary
Diabetic peripheral neuropathy is the most common complication of diabetes, affecting as many as 50% of patients. Circulation problems and loss of protective sensation associated with peripheral neuropathy can lead to greater risk of ulceration. Previous studies have indicated that diabetic patients have up to a 25% lifetime risk of developing a foot ulcer. However, prospective studies have demonstrated that screening for diabetic foot disease can successfully predict people at risk of ulceration. Various tests are used to detect peripheral neuropathy by assessing sense perception in the feet. The aim of this study is to estimate the sensitivity, specificity and other diagnostic accuracy parameters for VibraTip against the gold standard of sural nerve conduction velocity (SNCV) measurement, to assess whether tests using the VibraTip device offer superior diagnostic accuracy compared to other routine tests for peripheral neuropathy, and to examine whether diagnostic tests based on vibration, including VibraTip, offer superior diagnostic accuracy for peripheral neuropathy compared with touch based tests. NICE has commissioned the King’s Technology Evaluation Centre (KiTEC) to plan and obtain funding for this study. The study will take place at King’s College Hospital NHS Foundation Trust within the Diabetes and Diabetic Foot Clinics and within the Neurology department.
The study will include adults with diabetes type 2 who are due for check-up at a follow up clinic. Patients will be prospectively recruited. A cross-sectional study design will be employed to assess the diagnostic accuracy of 5 standard index tests for peripheral neuropathy, including VibraTip. The reference test will be sural nerve conduction velocity (SNCV) measurement. The outcomes assessed will be the diagnostic accuracy of the 5 index tests against SNCV measurement, including positive predictive value, negative predictive value, negative likelihood ratio and positive likelihood ratio. Receiver operating characteristic (ROC) curves will be constructed and compared for each test.
REC name
North of Scotland Research Ethics Committee 2
REC reference
15/NS/0102
Date of REC Opinion
1 Oct 2015
REC opinion
Favourable Opinion