Date of Approval:
Background: Diabetic Foot Ulcer (DFU) is one of the most severe complications of diabetes mellitus (DM). DFU substantially affects the morbidity, mortality and Quality of Life (QOL) in diabetic patients. Few studies have evaluated the economic consequences of DFU in England with limited level of detail in the correlation to patient characteristics and type of resource consumed. Purpose: This study aims to describe the clinical and economic burden attributable to DFU in England compared to diabetic with no DFU and to describe differences in clinical & economic burden among DFU population according to patient characteristics as well as healthcare pathways of DFU patients. Possible results and their significance: Results from this exploratory research will describe current DFU population, major health outcomes, as well as healthcare resource use and costs in England. Epidemiological investigations may help to document how DFU patients are managed and help decision makers to evaluate the impact of new incoming therapies on healthcare consumption.
Objective: To describe the population, the complications, the healthcare pathways, the resource uses (RU) and associated costs of DFU patients comparatively to diabetic non DFU patients. Methodology: A retrospective longitudinal matched-cohort study using data from the CPRD and linked Hospital Episode Statistics (HES) database will be conducted. Patients with a diagnosis of DFU or DM with no DFU will be included. The DFU population will be matched to the DM with no DFU population to have an accurate evaluation of costs that are attributable to DFU. Subgroups analyses will be performed for several health states and subpopulations e.g. patients with the first ulcer and with a recurrent ulcer. Data analysis: Descriptive analyses of patients' characteristics, complications, healthcare pathways will be performed using standard descriptive statistics for continuous variables (N, mean, standard deviation, etc) and for categorical variables (frequency tables). Risk of complications will be studied using adjusted logistic regression. Kaplan-Meier curves will be provided for time to complications. The effect on time to events will also be investigated using Cox regression, to adjust on patient characteristics and clinical history. Costs of DFU will be calculated as the sum of unit costs multiplied by the estimated quantities of resource use.
Samuel Aballea - Chief Investigator - Creativ-Ceutical
Julie Dorey - Corresponding Applicant - Creativ-Ceutical
David Neasham - Collaborator - Amgen Ltd