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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
Genaera Corporation
Information provided by (Responsible Party):
Abeona Therapeutics, Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Foot Ulcers Drug: ofloxacin Drug: MSI-78 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Drug: ofloxacin
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.
Drug: MSI-78
1%/2% topical cream twice a day for 14 days

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. microbiological response to therapy, [ Time Frame: Study day 10 ]
    Measure microbiological response to therapy

  2. Wound infection score [ Time Frame: Study day 10 ]
    Measure wound infection score.

  3. Total wound score [ Time Frame: Study day 10 ]
    Measure total wound score.

  4. Wound Area [ Time Frame: Study day 10 ]
    Measure wound area.

  5. Wound Depth [ Time Frame: Study day 10 ]
    Measure wound depth.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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

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United States, Washington
Seattle VA Medical Center
Seattle, Washington, United States, 98108-1597
Sponsors and Collaborators
Abeona Therapeutics, Inc
Genaera Corporation
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Study Director: Paul Litka, MD Magainin Pharmaceuticals, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abeona Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00563394    
Other Study ID Numbers: MSI-78-303
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Keywords provided by Abeona Therapeutics, Inc:
diabetes mellitus
oral antibiotic
topical cream
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors