– Adult patients aged over 18 years with systemic sclerosis meeting the 2013 ACR/EULAR criteria
– Patients with at least one active digital ischaemic ulcer, located beyond the proximal interphalangeal joint (but not situated on subcutaneous calcifications or bony prominences) and refractory after 10 ± 2 weeks of standard treatment in accordance with the recommendations of the National Scleroderma Care Programme (PNDS).
Patient-related:
– Patients who have been taking statins, vasodilators, calcium channel blockers, ACE inhibitors, nitroglycerine, α-adrenergic blockers, adrenergic or angiotensin II receptor antagonists, N-acetylcysteine or low-molecular-weight heparin for less than 3 months, or whose condition has been unstable for the past month;
– Systemic antibiotics (oral and intravenous) administered to treat infected digital ulcers within the past 4 weeks;
– Local injection of botulinum toxin into a finger within the past 4 weeks;
– Surgical sympathectomy of the upper limbs or wound debridement within the last month;
– Patients who have undergone an autologous haematopoietic stem cell transplant (HSCT) within the 12 months prior to inclusion;
– Patients for whom autologous HSCT is indicated as an escalation therapy;
– History of cancer within the last five years.
Relating to each digital ulcer:
– Digital ulcer caused by conditions other than scleroderma, non-ischaemic, with osteomyelitis or a clinically uncontrolled infection, or an infected ulcer requiring systemic antibiotic treatment or urgent surgical intervention.
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