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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 1996

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.


  • 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: ofloxacin
    • 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: MSI-78
    • 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

  • Reduction in clinical signs and symptoms of infection
    • Time Frame: Study day 10
    • 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 Measures

  • Microbiological response
    • Time Frame: Study day 10
    • Measure microbiological response to therapy
  • Wound infection score
    • Time Frame: Study day 10
    • Measure wound infection score
  • Total wound score
    • Time Frame: Study day 10
    • Measure total wound score
  • Wound area
    • Time Frame: Study day 10
    • Measure wound area.
  • Wound depth.
    • Time Frame: Study day 10
    • Measure wound depth.

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
    • Abeona Therapeutics, Inc
  • Collaborator
    • Genaera Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paul Litka, MD, Study Director, Magainin Pharmaceuticals, Inc.

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