MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
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|ClinicalTrials.gov Identifier: NCT00563394|
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : September 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcers||Drug: ofloxacin Drug: MSI-78||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||584 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers|
|Study Start Date :||August 1994|
|Actual Primary Completion Date :||July 1996|
|Actual Study Completion Date :||July 1996|
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
400 mg twice a day for 14 days
Other Name: Floxin
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.
1%/2% topical cream twice a day for 14 days
- Reduction in clinical signs and symptoms of the infection [ Time Frame: Study day 10 ]a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy
- microbiological response to therapy, [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563394
|United States, Washington|
|Seattle VA Medical Center|
|Seattle, Washington, United States, 98108-1597|
|Study Director:||Paul Litka, MD||Magainin Pharmaceuticals, Inc.|