Therapeutic options for DUs are few, with surgical amputation considered as the only definitive treatment for established DUs. Treatment for the prevention of new ulcers therefore addresses a true unmet medical need.
Treatment of DUs includes frequent local wound care, dressing changes and pain management. DUs are prone to infection and often require prolonged courses of intravenous antibiotics. A delay in treating the infection may lead to bone shortening and deformity.
Until recently, the evidence base for pharmacological treatment of DUs has been limited in both methodology and patient numbers. However, the similarities in the underlying vasculopathy of PAH and DUs provide the rationale for the use of a dual ET antagonist for prevention of DUs in patients with systemic sclerosis.
Results from two large randomized controlled trials support the use of a dual ET antagonist in DUs, showing an effect in reducing the number of new DUs in either patients with existing ulcerations or in patients with a history of DU disease.
Other pharmacological therapies which are routinely used for DUs, but with very limited evidence to support their efficacy are: