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