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 III

MedlinePlus related topics:

Antibiotics Diabetic Foot Foot Health

ChemIDplus related topics:

Levofloxacin Ofloxacin Ofloxacin hydrochloride Pexiganan Pexiganan acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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

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:	342
Study Start Date:	August 1994
Study Completion Date:	July 1996

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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: NCT00563433

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

Study ID Numbers:	MSI-78-304
First Received:	November 21, 2007
Last Updated:	November 21, 2007
ClinicalTrials.gov Identifier:	NCT00563433
Health Authority:	United States: Food and Drug Administration

Keywords provided by MacroChem Corporation:

diabetic

diabetes mellitus

foot

ulcers

Floxin

oral antibiotic

topical cream

Study placed in the following topic categories:

Foot Ulcer

Skin Diseases

Diabetic Neuropathies

Ulcer

Ofloxacin

Diabetes Mellitus

Vascular Diseases

Endocrine System Diseases

Foot Diseases

Diabetic Angiopathies

Endocrinopathy

Skin Ulcer

Diabetes Complications

Diabetic Foot

Leg Ulcer

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Bacterial Agents

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Anti-Infective Agents, Urinary

Enzyme Inhibitors

Cardiovascular Diseases

Renal Agents

Nucleic Acid Synthesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	MacroChem Corporation Genaera Corporation
Information provided by:	MacroChem Corporation
ClinicalTrials.gov Identifier:	NCT00563433