QTc Study
Research type
Research Study
Full title
Determination of QTc in the prediction of clinical outcome of people newly referred with ulcers of the foot in diabetes
IRAS ID
169215
Contact name
William Jeffcoate
Contact email
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
People with foot ulcers in diabetes are known to have reduced life expectancy, with only approximately 50% surviving more than 5 years. The cause of early death is thought to be mainly cardiovascular but the precise mechanism is not known. However, a specialist centre for foot disease in Sweden recently reported an association between mortality, some specific changes on ECG and the quality of blood sugar control (as reflected by the HbA1c) at the time of first referral (Fagher and Londahl, 2013). The change in the ECG concerned is called prolongation of the QTc interval and the Swedish group demonstrated that among 214 people with type 2 diabetes and with foot ulcers, QTc prolongation occurred in 46.7% of 81 people whose HbA1c control was good (HbA1c <58 mmol/mol; <7.5%) but in only approximately 30% of the remaining 133 whose control was less good. Mortality was over two and a half times greater in the subgroup with both an HbA1c <58 mmol/mol (<7.5%) and a prolonged QTc when compared with those with a prolonged QTc but a higher HbA1c, as well as with those with an HbA1c <58mml/mol (<7.5%) and a normal QTc. These differences were observed at two years from assessment but were more marked at 4, 6 and 8 years.
The aim of the present study is to confirm this observation in people attending a specialist foot service in the UK. The primary objective is to determine outcomes at 1, 2, 3, and 4 years. The study will be essentially observational, with data collected only at the time of first assessment and outcome determined via data routinely available to their carers via the computerised hospital records.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
15/NW/0318
Date of REC Opinion
27 Apr 2015
REC opinion
Further Information Favourable Opinion