Recommendations for the local management of digital ulcers in systemic sclerosis: A report from the World Scleroderma Foundation (WSF) 'Ad hoc committee'
- PMID: 40385097
- PMCID: PMC12084219
- DOI: 10.1177/23971983251339821
Recommendations for the local management of digital ulcers in systemic sclerosis: A report from the World Scleroderma Foundation (WSF) 'Ad hoc committee'
Abstract
Introduction: Digital ulcers (DUs) stand out as one of the most prevalent and clinically meaningful manifestations of systemic sclerosis (SSc) and are associated with significant morbidity. While systemic (pharmacological) therapy is currently established as the 'standard of care', effective local ulcer management remains crucial for all cases of DUs. This is particularly true for patients who cannot tolerate systemic treatments or in the case of refractory SSc-DUs. On this background, there is a pressing demand for the formulation of evidence-based guidelines to assist clinicians and patients in navigating the local treatment options for DUs.
Methods: A steering committee of international experts was established by the World Scleorderma Foundation (WSF) Digital Ulcer (DU) ad hoc committee. Two systematic literature reviews on local non-surgical and surgical treatments for the management of SSc-DUs were performed to inform the development of local treatment recommendations for SSc-DUs. Consensus methodology was used to develop the final treatment recommendations.
Results: Six overarching treatment principles and eight local treatment recommendations (five non-surgical and three surgical) were agreed upon for the management of SSc-DU. Among topical non-surgical options, botulin toxin can be conditionally recommended for refractory and/or severe DUs. Among surgical treatments, autologous adipose tissue grafting might be recommended for DU healing when combined with background systemic treatments.
Conclusion: These recommendations are specifically tailored to guide treatment decisions concerning both local and non-pharmacological approaches to managing SSc-related DUs. Our work has highlighted a notable quality gap in comparison to systemic treatments, underscoring the scarcity of high-quality studies concerning this topic.
Keywords: Systemic sclerosis; TIME; adipose tissue; botulin; debridement; digital ulcers; local treatment; non-pharmacological; scleroderma; surgical.
© The Author(s) 2025.
Conflict of interest statement
The author(s) declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: MH reports research funding and speaker fees from Janssen, outside of the submitted work. Chair of a Data Safety Monitoring Board: SHED SSc – SHarp dEbridement of Digital ulcers in Systemic Sclerosis: a multi-centre Randomised Controlled Trial feasibility study (REC reference: 21/YH/0278). MK has received consulting fees, speaking fees and/or research grants from Argenx, Asahi Kasei Parma, AstraZeneca, Boehringer Ingelheim, Chugai, GSK, Janssen, Kissei, MBL, Mochida, Ono Pharmaceuticals and Tanabe-Mitsubishi. LC has received consulting fees from Mitsubishi Tanabe, Genentech, Kyverna, IgM Biosciences, Lilly and Janssen. DG has received speaking fees from Boehringer Ingelheim and Janssen. OD has/had a consultancy relationship with and/or has received research funding from and/or has served as a speaker for the following companies in the area of potential treatments for systemic sclerosis and its complications in the last three calendar years: 4P-Pharma, AbbVie, Acceleron, Alcimed, Altavant, Amgen, AnaMar, Argenx, Arxx, AstraZeneca, Blade, Bayer, Boehringer Ingelheim, Cantargia AB, Catalyze Capital, Corbus, CSL Behring, Galderma, Galapagos, Glenmark, Gossamer, Horizon, Janssen, Kymera, Lupin, Medscape, Merck, Miltenyi Biotec, Mitsubishi Tanabe, Nkarta Inc, Novartis, Orion, Prometheus, Redxpharma, Roivant, EMD Serono, Topadur and UCB. Patent issued ‘mir-29 for the treatment of systemic sclerosis’ (US8247389, EP2331143). Co-founder of CITUS AG. None of the other authors report any relevant conflicts of interest.
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