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

This study has been completed.
Genaera Corporation
Information provided by:
MacroChem Corporation Identifier:
First received: November 21, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

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.

Condition Intervention Phase
Diabetic Foot Ulcers
Drug: ofloxacin
Drug: MSI-78
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

Resource links provided by NLM:

Further study details as provided by MacroChem Corporation:

Primary 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 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 ]

Enrollment: 584
Study Start Date: August 1994
Study Completion Date: July 1996
Arms Assigned Interventions
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
Drug: ofloxacin
400 mg twice a day for 14 days
Other Name: Floxin
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.
Drug: MSI-78
1%/2% topical cream twice a day for 14 days

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00563394

United States, Washington
Seattle VA Medical Center
Seattle, Washington, United States, 98108-1597
Sponsors and Collaborators
MacroChem Corporation
Genaera Corporation
Study Director: Paul Litka, MD Magainin Pharmaceuticals, Inc.
  More Information

No publications provided by MacroChem Corporation

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00563394     History of Changes
Other Study ID Numbers: MSI-78-303
Study First Received: November 21, 2007
Last Updated: November 21, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by MacroChem Corporation:
diabetes mellitus
oral antibiotic
topical cream

Additional relevant MeSH terms:
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents processed this record on April 17, 2014