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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)

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.

Interventions

  • 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 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

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • MacroChem Corporation
  • Collaborator
    • Genaera Corporation
  • Overall Official(s)
    • Paul Litka, MD, Study Director, Magainin Pharmaceuticals, Inc.

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