MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers|
- Primary outcome measure will be a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy [ Time Frame: Study day 10 ]
- Secondary outcome measure includes microbiological response to therapy, wound infection score, total wound score, wound area and wound depth. [ Time Frame: Study day 10 ]
|Study Start Date:||August 1994|
|Study Completion Date:||July 1996|
Active Comparator: 1
an oral antibiotic (ofloxacin 400 mg) twice a day and a placebo vehicle topical cream twice a day for 14 days, extended up to 28 days if clinically warranted
400 mg twice a day for 14 days
Other Name: Floxin
Active Comparator: 2
an oral placebo twice a day and MSI-78 1%/2% Topical Cream twice a day for 14 days, extended up to 28 days if clinically warranted.
1%/2% topical cream twice a day for 14 days
Approximately 224 adults will be enrolled in an outpatient Phase III study to compare the safety and efficacy of topically applied magainin peptide (MSI-78) to that of ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic, in the treatment of infected diabetic foot ulcers.
This is a randomized, controlled, double-blind trial that will involve twenty or more clinical centers.
|United States, Washington|
|Seattle VA Medical Center|
|Seattle, Washington, United States, 98108-1597|
|Study Director:||Paul Litka, MD||Magainin Pharmaceuticals, Inc.|