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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Drug: ofloxacin
* Drug: MSI-78


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ofloxacin<br>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<br>* 400 mg twice a day for 14 days<br>* Other names: Floxin;|
| Active Comparator: MSI-78<br>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<br>* 1%/2% topical cream twice a day for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in clinical signs and symptoms of infection | 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 | Study day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological response | Measure microbiological response to therapy | Study day 10 | 
| Wound infection score | Measure wound infection score | Study day 10 | 
| Total wound score | Measure total wound score | Study day 10 | 
| Wound area | Measure wound area. | Study day 10 | 
| Wound depth. | Measure wound depth. | Study day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic, diabetes mellitus, foot, ulcers, Floxin, oral antibiotic, topical cream