Diabetic foot ulcers (DFU) are a major complication in patients with Diabetes Mellitus. It is estimated that prevalence of DFU is 6.3% in the UK. These ulcers can develop in patients with either Type 1 or Type 2 Diabetes Mellitus. DFUs are complex and require a large amount of care. DFUs negatively impact on patients' health and are associated with several serious adverse outcomes. Patients with diabetes may have an increased risk of foot ulceration due to several underlying conditions.
Diabetes and frailty are two different but related conditions. Improvement in treatments and management of diabetes has resulted in patients with diabetes living longer. Frailty typically impacts on older adults, thus making this patient group more susceptible to suffering from frailty. Frailty is a complex condition that results in several physiological and behavioural changes, these have potential to contribute to the development of DFUs. Understanding the risk of diabetic foot ulceration in relation to frailty and its severity is therefore of preventative interest.
Once a patient develops a diabetic foot ulcer, adverse outcomes such as recurrent ulcers, cardiovascular events and death are common. There are several factors that may be associated with these adverse outcomes. These factors are typically measured as part of patient's routine care. Investigating the factors associated with adverse outcomes for patients with DFUs is key to highlight what modifiable risk factors could be targeted for treatment or prevention of these adverse outcomes.
This study will utilise data collected through the Clinical Practice Research Datalink (CPRD), data from CPRD Gold with linkage to Hospital Episode Statistics (HES) and Office for National Statistics (ONS) will be used.
This data will be used to investigate the risk of developing a diabetic foot ulcer in patients with diabetes in relation to frailty, measured by Electronic Frailty Index (eFI). Patients with diabetes can have an increased risk of foot ulceration. The presence of frailty alongside diabetes may increase this risk further. The dataset utilises existing patient information to indicate those that may be living with frailty. The varying levels are no frailty, mild, moderate or severe. This measure is easily generated and could be used as a quick measure to assess DFU risk.
A cohort of exposed individuals, defined as patients with a diagnosis of diabetes and DFU, will be used to investigate the factors associated with adverse outcomes (cardiovascular events, ulcer recurrence and mortality) in this population. This will help answer whether certain risk factors are associated with adverse outcomes in patients with diabetic foot ulcers. The adverse outcomes of interest are recurrent ulcers, cardiovascular events, and mortality.
The main outcomes of interest in this study are diabetic foot ulcers; recurrent diabetic foot ulcers; cardiovascular events; and mortality.
Liam Neal - Chief Investigator - University of Leicester
Francesco Zaccardi - Corresponding Applicant - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester
Matthew McCarthy - Collaborator - University of Leicester
Paddy Dempsey - Collaborator - University of Leicester
Sharmin Shabnam - Collaborator - University of Leicester
Tom Yates - Collaborator - University of Leicester
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation