Trends in incidence of first diabetic foot ulcer and mortality in patients with type I and type II diabetes mellitus

Study type
Protocol
Date of Approval
Study reference ID
19_027
Lay Summary

Diabetes Mellitus (DM) is a chronic disease, characterized by inappropriate levels of blood glucose and is often accompanied by severe complications. These complications can lead to disease in the most peripheral nerves, which alongside disease in the arterial blood vessels can lead to diabetic foot ulcers. Such ulcers often precede amputations, are associated with immobilization, impaired quality of life (QoL), and even increase the risk of early death. Much is already known about the risk factors for developing diabetic foot ulcers, but even in high-risk populations, the overall number of events each year is reported to be quite limited.

In this study, we want to investigate the trend in development of diabetic foot ulcers over time. Furthermore, we will describe these trends for several subgroups including people with type I and type II diabetes.

Technical Summary

In CPRD, all patients with a diagnosis of diabetes will be included in the initial study cohort.

Our primary outcome will be trends in incidence of first Diabetic Foot Ulcer (DFU).
Patients will be followed from the index date up to the date of death, end of data collection, end of study period, or the date of a DFU, whichever comes first. DFUs will be identified by use of read codes.

The incidence rates in each calendar year will be calculated as the sum of the DFUs in that year divided by the total time at risk in that given calendar year. This will be expressed as the number of events per 1000 person-years. We will break down these rates by gender, age categories, and type of diabetes (T1DM or T2DM).

Furthermore, the following patient characteristics at the time of the first DFU will be determined, age, time since index date as a proxy for diabetes duration and history of Charcot Neuroarthropathy (CN).

For patients with a diagnosis of a DFU we will also calculate the 1- and 5-year mortality rates.

All analyses will be stratified by sex, age categories and type of diabetes (T1DM and T2DM).

Health Outcomes to be Measured

1)     Trends in incidence of first DFU and hospitalization for first DFU
2) The following patient characteristics for all patients with a first DFU: age, duration of diabetes, history of CN at the date of the first DFU
3) 1- and 5-year mortality rates in patients with a first DFU.

Collaborators

Frank de Vries - Chief Investigator - Utrecht University
Frank de Vries - Corresponding Applicant - Utrecht University
Johan Roikjer - Collaborator - Aalborg University Hospital
Johanna Driessen - Collaborator - Utrecht University
Johannes T.H. Nielen - Collaborator - Utrecht University
Joop van den Bergh - Collaborator - Maastricht University
Morten Jensen - Collaborator - Aalborg University Hospital
Nicolaas Schaper - Collaborator - Maastricht University
Niels Ejskjaer - Collaborator - Aalborg University Hospital
Nikki Werkman - Collaborator - Utrecht University
Olaf Klungel - Collaborator - Utrecht University
Peter Vestergaard - Collaborator - Aalborg University Hospital