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

Phase 3 Completed 584 enrolled Abeona Therapeutics, Inc Genaera Corporation · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 1994-08
Primary completion: 1996-07
Completion: 1996-07

Publications

Lipsky BA, Holroyd KJ, Zasloff M. Topical versus systemic antimicrobial therapy for treating mildly infected diabetic foot ulcers: a randomized, controlled, double-blinded, multicenter trial of pexiganan cream. Clin Infect Dis. 2008 Dec 15;47(12):1537-45. doi: 10.1086/593185.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	MSI-78	Unknown	1 %	Topical
Comparator	MSI-78	Unknown	2 %	Topical
Comparator	Ofloxacin	Small molecule	400 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications