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

NCT00563394 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 584

Last updated 2020-09-03

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcers

Interventions

DRUG

ofloxacin

400 mg twice a day for 14 days

DRUG

MSI-78

1%/2% topical cream twice a day for 14 days

Sponsors & Collaborators

  • Genaera Corporation

    collaborator INDUSTRY

  • Abeona Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Paul Litka, MD · Magainin Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-08-31
Primary Completion
1996-07-31
Completion
1996-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00563394 on ClinicalTrials.gov