SANGUINATE™ in Sickle Cell Disease Associated Leg Ulcer

Inclusion Criteria: * Properly consented patients suffering from Sickle Cell Disease (Hb-SS or Hb- Sβ° genotype) associated Leg ulcer. * Presence of leg ulcer for at least 4 weeks * Venous Clinical Severity Score of moderate to severe (defined as ≥12) * Leg ulcer below the knee Exclusion Criteria: * Patient presenting with a clinically \& laboratory confirmed bacterial, fungal or acid fast organisms * Patient has a recent acute complication of Sickle Cell Disease (e.g., pain crisis within 7 days, or acute chest syndrome within 21 days) * Patient is planning to be pregnant, is pregnant, or is breast-feeding * Presence of moderate to severe renal insufficiency (CrCl \< 30 mL/min) or chronic kidney disease, or of moderate to severe hepatic insufficiency (Child-Pugh class B or C) * Patients with more than 3 times the upper limit of normal laboratory reference range * Concurrent or recent prior treatment (within 90 days) with an investigational medication * Patients currently receiving treatment with hydroxyurea must be on stable dose for at least 30 days * Receipt of a blood transfusion within 21 days