Clinical trial NCT00563394: MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
Official title: MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Foot Ulcers
Keywords: diabetic
diabetes mellitus
foot
ulcers
Floxin
oral antibiotic
topical cream
Lead sponsor: Abeona Therapeutics, Inc
Sponsor class: INDUSTRY
Collaborators: name: Genaera Corporation
First posted: 2007-11-26
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Reduction in clinical signs and symptoms of the infection
timeFrame: Study day 10
Secondary outcomes:
measure: microbiological response to therapy,
timeFrame: Study day 10
measure: Wound infection score
timeFrame: Study day 10
measure: Total wound score
timeFrame: Study day 10
measure: Wound Area
timeFrame: Study day 10
measure: Wound Depth
timeFrame: Study day 10
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle VA Medical Center
state: Washington
Study officials:
affiliation: Magainin Pharmaceuticals, Inc.
name: Paul Litka, MD
role: STUDY_DIRECTOR
References:
citation: 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.