A newly developed core outcome set (COS) aims to standardize the evaluation of interventions for diabetes-related foot ulceration (DFU) in research. Published in Diabetes Care, the COS is designed to ensure consistent and relevant data collection across different studies, ultimately improving the comparability and synthesis of research findings. This initiative addresses a critical need in DFU research, where heterogeneity in outcome reporting has hindered the development of evidence-based guidelines.
The COS includes a set of key outcomes identified as essential for evaluating the effectiveness of DFU interventions. These outcomes encompass:
- Complete ulcer closure
- Amputation (major and minor)
- Infection
- Health-related quality of life
- Time to ulcer closure
- Pain
The development of the COS involved a rigorous methodology, including a Delphi process with international experts from various disciplines, such as vascular surgery, podiatry, and diabetology. This process ensured that the COS reflects a broad consensus on the most important outcomes for DFU research.
Impact on Clinical Practice
The implementation of this COS is expected to have a significant impact on clinical practice by facilitating the development of more robust evidence-based guidelines for DFU management. By standardizing outcome reporting, researchers will be able to more easily compare the effectiveness of different interventions and identify the most promising approaches for improving patient outcomes.
Addressing Unmet Needs
DFU represents a major complication of diabetes, affecting millions of people worldwide and leading to significant morbidity, mortality, and healthcare costs. The lack of standardized outcome reporting in DFU research has been a major obstacle to progress in this field. The development of this COS represents a crucial step forward in addressing this unmet need and improving the lives of people with diabetes.
