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

Purpose

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	Intervention	Phase
Diabetic Foot Ulcers	Drug: ofloxacin Drug: MSI-78	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Diabetes Diabetic Foot Foot Health

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by MacroChem Corporation:

Primary Outcome Measures:

Primary outcome 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 [ Time Frame: Study day 10 ]

Secondary Outcome Measures:

Secondary outcome measure includes microbiological response to therapy, wound infection score, total wound score, wound area and wound depth. [ Time Frame: Study day 10 ]

Enrollment:	584
Study Start Date:	August 1994
Study Completion Date:	July 1996

Arms	Assigned Interventions
Active Comparator: 1 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: 2 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563394

Locations

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

Sponsors and Collaborators

MacroChem Corporation

Genaera Corporation

Investigators

Study Director:

Paul Litka, MD

Magainin Pharmaceuticals, Inc.

More Information

No publications provided by MacroChem Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00563394 History of Changes
Other Study ID Numbers:	MSI-78-303
Study First Received:	November 21, 2007
Last Updated:	November 21, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by MacroChem Corporation:

diabetic
diabetes mellitus
foot
ulcers

Floxin
oral antibiotic
topical cream

Additional relevant MeSH terms:

Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus

Endocrine System Diseases
Diabetic Neuropathies
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on May 23, 2013