To compare the rates of clinical success of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in subjects with mild diabetic foot infections in non-ischemic ulcers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Topical Dermacyn once a day for 10 Days
Topical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days
Topical saline once a day and levofloxacin 750 mg PO daily, both for 10 days
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
La Jolla, California, United States
Unnamed facility
Los Angeles, California, United States
To compare the rates of clinical success (cure + improvement) of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in patients with mild diabetic foot infections in non ischemic ulcers
Time frame: Visit 3 (Day 10); Visit 4 (Day 24)
To compare the treatment groups with respect to microbiological outcome. Incidence of adverse events and other safety outcomes
Time frame: Visit 2 (Day 3); Visit 3 (Day 10)
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Unnamed facility
San Diego, California, United States
Unnamed facility
Santa Rosa, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
New Haven, Connecticut, United States
Unnamed facility
Boca Raton, Florida, United States
Unnamed facility
Spring Hill, Florida, United States
Unnamed facility
Evansville, Indiana, United States
...and 6 more locations