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

Condition(s) targeted: Diabetic Foot Ulcers

Intervention: ofloxacin (Drug); MSI-78 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: MacroChem Corporation

Official(s) and/or principal investigator(s):
Paul Litka, MD, Study Director, Affiliation: Magainin Pharmaceuticals, Inc.

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: Secondary outcome measure includes microbiological response to therapy, wound infection score, total wound score, wound area and wound depth.

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Seattle VA Medical Center, Seattle, Washington 98108-1597, United States

Starting date: August 1994
Last updated: November 21, 2007