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Seattle, Washington 98108


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 summary:

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.


Inclusion Criteria: - 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 basis - 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 foot - Patient may not be taking or have received any other investigational therapy or approved therapy within 30 days prior to entry Exclusion Criteria: - 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 affected foot - Other conditions considered by the investigator to be sound reason for disqualification - 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



Primary Contact:

Study Director
Paul Litka, MD
Magainin Pharmaceuticals, Inc.

Backup Contact:


Location Contact:

Seattle, Washington 98108
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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