The trial will be conducted at approximately 70 sites in the U.S. and is expected to enroll approximately 700 patients. The study will have 90 percent power to detect a 15 percent absolute benefit for repifermin over placebo. We have worked with the leaders of the wound-healing community to design this definitive trial and look forward to continued successful collaborations with them and others as we proceed with the development of repifermin. Venous ulcers are lesions on the skin of the ankle or lower leg. They are caused by chronic venous insufficiency, which leads to pooling of blood in the extremities, causing swelling and mild redness and scaling of the skin that leads to ulceration.
Venous ulcers can take more than a year to heal.
Current therapy protocols for these wounds include compression dressing, management of infection and debridement and may involve skin substitutes. However, treatment often extends for several months and frequently ends without success. In the U.S., it is conservatively estimated that 400,000 to 600,000 patients suffer from venous ulcers each year. Similar data have been reported from Europe. This prevalance is accompanied by substantial costs.