Sickle Cell Anemia Clinical Trial
Official title:
Phase II Trial of Arginine Butyrate for Treatment of Refractory Leg Ulcers in Sickle Cell Disease or Beta Thalassemia
OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate
in terms of healing rate in patients with refractory sickle cell ulcers.
II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion
or inhibition of wound healing in these patients.
III. Determine whether the regimen used in this study is appropriate for testing in pivotal
trials.
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of
two treatment arms. Arm I: Patients receive arginine butyrate IV over 6-9 hours at night 5
days a week for 12 weeks, plus concurrent standard local therapy consisting of cleaning,
saline irrigation, and dressing changes as prescribed by each patient's physician. Patients
who experience progressive healing receive arginine butyrate 3-4 times a week. Arginine
butyrate treatment may be discontinued and reinstated following a single 2 week medical
complication.
Arm II: Patients receive standard local therapy alone for 12 weeks. Patients randomized to
arm II may cross over to receive arginine butyrate if no or less than 25% healing is
observed after 12 weeks.
Patients whose ulcers have closed by at least 15% per cycle may receive 2 additional 8-week
cycles of arginine butyrate therapy and are followed for 2 months after healing is
completed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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