MRI biomarkers of diabetes-related foot disease
Research type
Research Study
Full title
Early detection of diabetes-related foot disease using magnetic resonance imaging biomarkers.
IRAS ID
352806
Contact name
Dinesh Selvarajah
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Common complications that occur in the upper and lower limbs of patients with diabetes mellitus (DM) are arterial plaque build-up (diabetes-related peripheral arterial disease (PAD)) and nerve damage (diabetic peripheral neuropathy (DPN)).
Due to a loss in the protective sensation of the feet combined with slow wound healing caused by ischaemia and infections, major lower limb amputations are a common complication of DM. As a result, DM is one of the leading causes of non-traumatic lower limb amputations worldwide. Furthermore, macro- and microvascular abnormalities result in significant end-organ damage leading to increased morbidity and premature mortality.
In most instances, by the time patients are symptomatic, the underlying vascular pathology and nerve damage are well advanced. Furthermore, most surrogate biomarkers used to assess macro- and microvascular complication of diabetes rely on indirect measures of structure and function. Early detection is therefore critical for disease management and minimising the risk of complications.
Previous studies have shown that MRI biomarkers can detect early nerve and vasculature damage caused by diabetes, but there is a distinct lack of data in the feet specifically. The aim of this study is to provide technical validation that in vivo multiparametric MRI biomarkers can detect diabetes-related PAD and DPN in the foot.
Two groups of participants will be recruited: Ten participants aged ≥18 years old with Type 2 Diabetes (T2D) and clinical diabetes-related PAD and DPN, and ten age- and sex-matched control participants without diabetes. After screening and consent, each participant will attend two hospital visits no less than 7 days apart. Each participant will undergo detailed clinical and neurophysiological assessments during the first visit, followed by an MRI scanning session during the second visit. Participants will be instructed to avoid hypoglycaemia for 24 hours before each visit.
REC name
Wales REC 3
REC reference
25/WA/0108
Date of REC Opinion
31 Mar 2025
REC opinion
Favourable Opinion