Effectiveness and safety of low-energy shock wave therapy for digital ulcers associated with systemic sclerosis: A Phase 3 pivotal clinical trial

Abstract

Objectives: Systemic sclerosis (SSc) is characterised by ischaemic skin ulcers on the fingertips, and low-energy shock wave therapy is suggested as a novel treatment for ischaemic lesions with angiogenic effects. We aimed to investigate the efficacy and safety of shock wave therapy for skin ulcers in patients with SSc.

Methods: In this Phase 3 pivotal study, we analysed 60 SSc patients with digital ulcers that did not disappear after >4 weeks of existing treatment: 30 patients were treated with extracorporeal shock wave therapy and 30 with conventional treatment. The ulcer count reduction observed after an 8-week treatment period was compared between the shock wave therapy and conventional treatment groups.

Results: After an 8-week treatment period, the mean reduction in the number of ulcers was 0.83 (SD 2.79) in the conventional treatment group compared to a more pronounced reduction of 4.47 (SD 2.65) in the shock wave therapy group.

Conclusions: The study findings indicate the efficacy of extracorporeal shock wave therapy for refractory digital ulcers associated with SSc, which has limited therapeutic options. This therapy is non-invasive and safe and can be used without restriction in combination with other therapies, thus serving as a novel therapeutic method.

Keywords: Digital ulcer; Raynaud’s phenomenon; extracorporeal shock wave therapy; neovascularisation; systemic sclerosis.