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

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