NCT00563394

MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 584 (actual)
• Sponsor: Abeona Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DRUG	ofloxacin	400 mg twice a day for 14 days
DRUG	MSI-78	1%/2% topical cream twice a day for 14 days

Timeline

• Start date: 1994-08-01
• Primary completion: 1996-07-01
• Completion: 1996-07-01
• First posted: 2007-11-26
• Last updated: 2020-09-03

Locations

1 site across 1 country: United States