FRI0501 Fate of Collagen Disease Related Digital Skin Ulcers Treated Only under Currently Approved Therapies: A Control Study Comparing with the New Shockwave Therapy toward Digital Ulcers of Scleroderma

Background Patients with collagen diseases such as Scleroderma display Raynaud syndrome which sometimes causes digital skin ulcers. As these ulcers do not depend on autoimmune or abnormal coagulation, conventional immunosuppressive therapies and anti-coagulant agents are often ineffective. We have introduced extracorporeal shock waves therapy (ESWT) to 9 scleroderma patients with indolent skin ulcers and have demonstrated its unprecedented effect for curing existing ulcers1. However, these ulcers are seasonal and usually appear in winter and sometimes heal spontaneously in spring. Therefore we might have seen merely this natural course of seasonal healing in ESWT study. Objectives To distinguish pure EWST effect from spontaneous seasonal healing, we have studied a group of collagen disease patients with digital ulcers who were treated conventionally without ESWT for the transiton of ulcers during seasonal changes, in parallel with the shockwave treatment group. Methods 17 facilities in the Tohoku region of Japan were registered for collaboration and 25 patients with existing digital ulcers from 13 facilities have been enrolled. Inclusion and exclusion criteria and observation period was the same in the EWST trial. Monthly observation started on December 2012, counting the number of skin ulcers and checking the physical disability index of HAQ, EQ-5D and pain VAS, monthly. Results 15 (12 Scleroderma and 3 SLE) patients completed 8 week observation. All 15 are female and had been treated with anticoagulants, including 3 patients having received intravenous prostaglandin E1. As expected, in 8 weeks few ulcers were improvemed and only non-significant increase in the number of ulcers during first 4 weeks and decreased during next 4 weeks were observed (Fig1). By contrast, ESWT treated patients marked drastic improvement rapidly after the first treatment (Fig2), resulting in a decrease from 5.4 per person to 1.1 in 8 weeks. Moreover, HAQ, EQ5D and pain VAS showed little changes without ESWT but were improved significantly with ESWT. Conclusions In this natural history observation, most collagen disease related skin ulcers appeared in Scleroderma and the disease should be recognized as requiring highest care. Those existing ulcers were not cured with temporary available therapies in 8 weeks including spontaneous healing during seasonal changes. Comparing with this natural course of the ulcers, the definite effect of ESWT could be proven and it may possibly be con