Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: ofloxacin
  • 400 mg twice a day for 14 days
• Drug: MSI-78
  • 1%/2% topical cream twice a day for 14 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • an oral antibiotic (ofloxacin 400 mg) twice a day and a placebo vehicle topical cream twice a day for 14 days, extended up to 28 days if clinically warranted
• Active Comparator: 2
  • an oral placebo twice a day and MSI-78 1%/2% Topical Cream twice a day for 14 days, extended up to 28 days if clinically warranted.

Primary Measures

• 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
  • Time Frame: Study day 10
    

Secondary Measures

• Secondary outcome measure includes microbiological response to therapy, wound infection score, total wound score, wound area and wound depth.
  • Time Frame: Study day 10
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: MacroChem Corporation

Overall Clinical Trial Officials and Contacts

Paul Litka, MD Study Director Magainin Pharmaceuticals, Inc.  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00563394

Study ID Number: MSI-78-303

ClinicalTrials.gov Identifier: NCT00563394

Health Authority: United States: Food and Drug Administration