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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Drug: ofloxacin; Drug: MSI-78

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.

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108-1597
      • Seattle VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abeona Therapeutics, Inc
• Collaborators: Genaera Corporation
• Investigators: Study Director: Paul Litka, MD, Magainin Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• 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. doi: 10.1086/593185.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 1994
• Primary Completion (Actual): July 1, 1996
• Study Completion (Actual): July 1, 1996

Study Registration Dates

• First Submitted: November 21, 2007
• First Submitted That Met QC Criteria: November 21, 2007
• First Posted (Estimate): November 26, 2007

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: diabetes mellitus; foot; ulcers; diabetic; topical cream; oral antibiotic; Floxin
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Ofloxacin
• Other Study ID Numbers: MSI-78-304