Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers
Status:
Completed
Trial end date:
2005-02-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Susan P. Perrine
Collaborators:
Boston Medical Center Icahn School of Medicine at Mount Sinai Schneider Children's Medical Center, Israel University of Illinois at Chicago University of Tennessee Health Science Center