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

This study has been completed.
Sponsor:
Collaborator:
Genaera Corporation
Information provided by:
MacroChem Corporation
ClinicalTrials.gov Identifier:
NCT00563394
First received: November 21, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

November 21, 2007
November 21, 2007
August 1994
Not Provided
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 ]
Same as current
No Changes Posted
Secondary outcome measure includes microbiological response to therapy, wound infection score, total wound score, wound area and wound depth. [ Time Frame: Study day 10 ]
Same as current
Not Provided
Not Provided
 
MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Foot Ulcers
  • Drug: ofloxacin
    400 mg twice a day for 14 days
    Other Name: Floxin
  • Drug: MSI-78
    1%/2% topical cream twice a day for 14 days
  • 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
    Intervention: Drug: ofloxacin
  • 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.
    Intervention: Drug: MSI-78
Lipsky BA, Holroyd KJ, Zasloff M. Topical versus systemic antimicrobial therapy for treating mildly infected diabetic foot ulcers: a randomized, controlled, double-blinded, multicenter trial of pexiganan cream. Clin Infect Dis. 2008 Dec 15;47(12):1537-45.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
584
July 1996
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00563394
MSI-78-303
No
Not Provided
MacroChem Corporation
Genaera Corporation
Study Director: Paul Litka, MD Magainin Pharmaceuticals, Inc.
MacroChem Corporation
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP