Trial | NCT00563433  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    342
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.
Study Started
Aug 31
1994
Primary Completion
Jul 31
1996
Study Completion
Jul 31
1996
Last Update
Sep 03
2020

Drug MSI-78

1%/2% topical cream twice a day for 14 days

Drug ofloxacin

400 mg twice a day for 14 days

  • Other names: Floxin

ofloxacin Active Comparator

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

MSI-78 Active Comparator

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.

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
No Results Posted