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
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
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.
- 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
- 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.
Clinical Trial Outcome 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 outcome measure includes microbiological response to therapy, wound infection score, total wound score, wound area and wound depth.
- Time Frame: Study day 10
Participating in This Clinical Trial
- 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
- 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: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- MacroChem Corporation
- Genaera Corporation
- Overall Official(s)
- Paul Litka, MD, Study Director, Magainin Pharmaceuticals, Inc.
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