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Phase II Randomized Trial of Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers
This study is currently recruiting patients.
Sponsored by: | FDA Office of Orphan Products Development Boston University School of Medicine
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Information provided by: | FDA Office of Orphan Products Development |
Purpose
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.
Condition | Treatment or Intervention | Phase |
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Skin Ulcers Sickle Cell Anemia |
Drug: arginine butyrate |
Phase II |
MedlinePlus related topics: Sickle Cell Anemia; Skin Diseases
Genetics Home Reference related topics: sickle cell anemia
Study Type: Interventional
Study Design: Treatment, Randomized
Expected Total Enrollment: 30
Study start: September 1997
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 only 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 course may receive 2 additional 8-week courses of arginine butyrate therapy and are followed for 2 months after healing is completed.
Eligibility
Ages Eligible for Study: 16 Years - 60 Years, Genders Eligible for Study: Both
Criteria
Location and Contact Information
More Information
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