Phase II Randomized Trial of Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||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.
|United States, Illinois|
|University of Illinois College of Medicine||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Mabel Koshy 312-996-5680|
|United States, Massachusetts|
|Boston University School of Medicine||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Susan Park Perrine 617-638-4173|
|United States, New York|
|Mount Sinai School of Medicine||Recruiting|
|New York, New York, United States, 10029|
|Contact: George F. Atweh 212-785-6662|
|United States, Tennessee|
|University of Tennessee, Memphis Cancer Center||Recruiting|
|Memphis, Tennessee, United States, 38103|
|Contact: Patricia E. Adams-Graves 901-448-5798|
|Study Chair:||Douglas V. Faller||Boston University|