Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine

Inclusion Criteria: * Subject gave voluntary written informed consent to participate in the study * Diagnosis of systemic sclerosis (SSc) as defined by American College of Rheumatology (ACR) criteria * Males and females age greater than 18 years at Screening * Presence of at least one active digital ulcer (met protocol defined qualifications for active digital ulcer) at Baseline * Females of childbearing potential willing to use a reliable form of medically acceptable contraception and have a negative pregnancy test at Screening and Baseline * Able to communicate effectively with study personnel and willing to comply with protocol requirements Exclusion Criteria: * Diagnosis of pulmonary arterial hypertension (PAH) * Body weight less than 40 kg at Screening and confirmed at Baseline * History of postural hypotension, unexplained syncope, a blood pressure that is less than 90 mmHg systolic or 50 mmHg diastolic at Screening and Baseline * Hemoglobin concentration less than 75% of the lower limit of the normal range at Screening * Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C, or ALT greater than three times upper limit of normal * Intractable diarrhea, or severe malabsorption, defined as greater than 15% unintentional loss of body weight in the last 6 months prior to Screening; any severe organ failure (e.g., lung, kidney), bleeding diathesis or platelet disorder, or any life-threatening condition * Pregnant or breast-feeding * Simultaneously fulfilled…