A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).

Inclusion Criteria:

• Diagnosis of limited or diffuse systemic sclerosis (SSc) according to American College of Rheumatology or LeRoy criteria
• Age greater than 18 years of age
• At least one digital ulcer located on the volar or lateral surface at or distal to the proximal interphalangeal joints
• At least one new DU that developed within 12 weeks prior to screening
• Vasodilator therapies, including calcium channel blockers, alpha-1-antagonists, ACE-inhibitors, nitroglycerin, and angiotensin receptor blockers, are permitted as long as the doses are stable for 2 weeks prior to screening and throughout the study
• Treatment with omeprazole or other proton pump inhibitors must be stable for 2 weeks prior to screening and throughout the study

Exclusion Criteria:

• Patients with pulmonary arterial hypertension, NYHA Class III or IV
• Patients who are hemodynamically unstable, or have acute renal, cardiac or pulmonary failure
• Concurrent malignancy except non-melanoma skin cancers
• Patients who have required systemic antibiotics for infected digital ulcers within 2 weeks of screening
• Patients receiving phosphodiesterase-5 inhibitors, endothelin receptor antagonists, or prostanoids within 4 weeks of screening
• Patients receiving cyclosporine within 6 weeks of screening
• Patients who have participated in any investigational study within 30 days of screening
• Pregnant or nursing women
• Patients with a history of drug or alcohol abuse within 6 months of screening
• History of hepatitis B, hepatitis C, or HIV infection
• Any medical condition that, in the opinion of the investigator, might interfere with the subject's participation in the study or poses an added risk for the subject
• Inability to comply with study and follow-up procedures
• Transaminase elevation > 3X the upper limit of normal at screening
• Hemoglobin less than 8.5 g/dL
• Platelet count less than 100 X 109/L
• White blood cell count less than 3.0 X 109/L
• Serum creatinine less than 2.0 mg/dL