Points to consider for reporting digital ulcers in systemic sclerosis interventional studies: An initiative from the world Scleroderma Foundation digital ulcer ad hoc committee

Background: Digital ulcers (DUs) are among the most painful and functionally disabling complications of systemic sclerosis (SSc), affecting up to 50% of patients. Despite their clinical relevance, interventional studies on DUs are limited and vary widely in design, definitions, and outcome reporting, hindering comparability and the development of standardized treatment approaches. Objectives: This initiative, led by an international expert group under the World Scleroderma Foundation (WSF), aims to establish points to consider for the standardized reporting of DUs in interventional studies, improving study quality, interpretability, and clinical relevance. Methods: A steering committee of SSc experts developed these recommendations based on three systematic literature reviews on local, surgical, and systemic treatments for SSc-DUs. Consensus was achieved through iterative discussion among committee members, without external funding or third-party influence. Results: Seven domains were identified as essential for standardization: (1) a uniform definition and classification of DUs; (2) consistent inclusion and exclusion criteria; (3) standardized primary and secondary outcome measures, including clinical and patient-reported outcomes; (4) detailed reporting of background and concomitant therapies; (5) harmonized local wound care protocols; (6) predefined timing and frequency of assessments; and (7) consideration of seasonal and environmental influences. Conclusion: Adopting these standardized reporting principles in future DU trials will enhance the quality and comparability of data, support more robust meta-analyses, and facilitate the development of effective, patient- centered treatment strategies for SSc-related DUs.