Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration

Area of Science:

• Endocrinology and Metabolism
• Podiatry and Wound Care
• Clinical Trial Methodology

Background:

• Diabetes mellitus impacts over 537 million individuals globally, with a significant portion developing foot complications.
• Diabetes-related foot ulceration presents a substantial global health burden, necessitating standardized evidence for effective management.
• Existing research on treatments for diabetic foot ulcers exhibits outcome heterogeneity, hindering comparative analysis.

Purpose of the Study:

• To develop a standardized core outcome set (COS) for clinical trials evaluating treatments for diabetes-related foot ulceration.
• To ensure consistent measurement of outcomes in research, facilitating robust comparisons of interventions.
• To address the heterogeneity in outcome reporting in studies of diabetic foot ulcer treatments.

Main Methods:

• Utilized the Core Outcome Measures in Effectiveness Trials (COMET) methodology.
• Conducted a systematic review and patient interviews to identify candidate outcomes.
• Employed a two-round Delphi survey with patients and experts, followed by a consensus meeting to ratify the COS.

Main Results:

• Generated 103 candidate outcomes from the initial review and interviews.
• Achieved a 52% response rate across two Delphi rounds involving 336 and 176 participants.
• Ratified an 8-item COS including wound healing, time to healing, infection, amputation, quality of life, and mortality.

Conclusions:

• A consensus-based core outcome set (COS) for diabetes-related foot ulcer research has been established.
• The adoption of this COS is expected to enhance the assessment of comparative effectiveness for current and novel treatments.
• Standardized outcome measurement will improve the quality and comparability of evidence in diabetic foot ulcer research.