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

This study has been completed.
Sponsor:
Collaborator:
Genaera Corporation
Information provided by:
MacroChem Corporation
ClinicalTrials.gov Identifier:
NCT00563433
First received: November 21, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by MacroChem Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00563433     History of Changes
Other Study ID Numbers: MSI-78-304
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
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
Ofloxacin
Levofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 16, 2014