MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
Information source: MacroChem Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Foot Ulcers
Intervention: ofloxacin (Drug); MSI-78 (Drug)
Phase: Phase 3
Sponsored by: MacroChem Corporation
Official(s) and/or principal investigator(s):
Paul Litka, MD, Study Director, Affiliation: Magainin Pharmaceuticals, Inc.
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
Official title: MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Secondary outcome: Secondary outcome measure includes microbiological response to therapy, wound infection score, total wound score, wound area and wound depth.
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
Minimum age: 18 Years.
Maximum age: N/A.
- Non-hospitalized ambulatory patients with diabetes mellitus
- Men or Women greater than 18 years old
- Patients must be considered reliable, willing and able to give consent
- Female patients must be postmenopausal for a least 6 months or surgically sterilized
- Localized infection of the ulcer that would ordinarily be treated on an outpatient
- Patients who have been previously treated or are currently under treatment for a
localized infections of an ulcer may be enrolled in there has been an adequate
response to treatment and ulcer is still infected
- Patient must have radiograph within two weeks of entry showing no evidence of cortical
destruction consistent with osteomyelitis
- Patient must have a palpable dorsalis pedis or posterior tibial pulse in the affected
- Patient may not be taking or have received any other investigational therapy or
approved therapy within 30 days prior to entry
- Patients requiring concurrent local or systemic antimicrobials during the study period
for other infections
- Patients who are currently treated or awaiting dialysis
- Patients who are unable to care for their ulcers
- Patients with known alcohol or substance abuse within 6 months or study entry
- Patients with significant GI problems or surgery that might interfere with the
absorption of ofloxacin
- Patients who are currently receiving systemic corticosteroids, immunosuppressives,
antivirals, radiation therapy or cytotoxic agents
- Patients who currently require treatment or a primary or metastatic malignancy or have
systemically immunocompromising disease.
- Previous enrollment in this study or previous treatment with MSI-78 Topical Cream
- Patients with gangrene or severely impaired arterial supply to any portion of the
- Other conditions considered by the investigator to be sound reason for
- Patients with any known allergy to ofloxacin, other quinolone antibiotics, magainin
peptides or ingredients of the vehicle cream
- Women who are breast feeding, pregnant or attempting to become pregnant
Locations and Contacts
Seattle VA Medical Center, Seattle, Washington 98108-1597, United States
Starting date: August 1994
Ending date: July 1996
Last updated: November 21, 2007