Objective: In this pilot study, the effect of sildenafil on digital ulcer (DU) healing and related clinical symptoms was analysed.
Methods: 19 systemic sclerosis (SSc) patients were treated with maximally tolerated sildenafil doses up to 6 months. Primary outcome was the healing of DU. Furthermore, changes in other clinical symptoms were evaluated.
Results: 49 DU were present at baseline that decreased to 17 ulcers (p < 0.001) at the end of sildenafil therapy. Furthermore, the visual analogue scale score for Raynaud’s phenomenon (RP), pain, and activity improved (p = 0.003, p = 0.002, and p = 0.05, respectively). Nine patients developed 12 new DU during sildenafil therapy.
Conclusions: This study indicates an effect of sildenafil on DU healing in SSc patients, improvement of RP and associated symptoms that should be validated in controlled studies.