|Medical Officer, MD, PhD|
4 United States sites
> 18 Years
Phase 1/Phase 2
1. Male or female, >18 years of age
2. Diagnosed with Sickle Cell Disease (SS, SC, Sß-thalassemia, SD, SOArab)
3. Cutaneous ulcer with a University of Texas Wound Classification System Grade 1A or 2A
(= Wagner class 1or 2, without infection or ischemia)
4. Ulcer on lower leg, ankle, or dorsum of foot
5. Vascular status of site assessed and judged adequate for healing (per Section 4.2)
6. Ulcer present ≥ 14 days but not > 6 months at time of screening
7. Ulcer 2.0 cm2 to 45.0 cm2 and < 6.0 cm diameter at widest point after debridement, prior to randomization. 8. Ulcer healed by < 25% during the SOC run-in period prior to Visit 4 randomization. 9. Subject is willing to use acceptable form of birth control (per Section 4.2) during trial and for one month thereafter
1. Active infection/purulence at ulcer site, based on Investigator’s clinical judgement
2. Current or history of osteomyelitis at or near site of ulcer
3. Serum albumin < 2.0 g/dL 4. Treatment with systemic DFO within 7 days of study entry 5. Serum ferritin > 1000 ng/mL
6. Subjects requiring, or expected to require, iron chelation therapy (systemic
deferoxamine, deferasirox, or deferiprone) during the duration of the study.
7. Subjects on dialysis or with evidence of nephrotic syndrome.
8. Known bleeding or coagulation disorder that would preclude surgical debridement, as
9. The subject has a major uncontrolled medical disorder, such as serious cardiovascular,
renal, liver, pulmonary disease, or pulmonary disease (per Investigator discretion).
10. Any condition that in the Investigator’s opinion would warrant exclusion from the
study or prevent the subject from completing the study
11. Previous participation in another clinical trial within 30 days prior to study entry