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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Douglas V. Faller
Study Chair
Boston University
United States: Federal Government
199/13302
NCT00004412
September 1997
Name | Location |
---|---|
Mount Sinai School of Medicine | New York, New York 10029 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
Boston University School of Medicine | Boston, Massachusetts 02118 |
University of Illinois College of Medicine | Chicago, Illinois 60612 |