The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care, as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
189
Unnamed facility
Birmingham, Alabama, United States
Number of Participants With Clinical Response
The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
Time frame: 28 days
Number of Participants With Microbiological Success
The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported.
Time frame: 28 days
Number of Participants With Treatment-emergent Adverse Events (TEAE)
The numbers of participants with TEAEs, including those with Serious TEAEs, are reported
Time frame: 28 days
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Unnamed facility
Glendale, Arizona, United States
Unnamed facility
Mesa, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Jonesboro, Arkansas, United States
Unnamed facility
Bakersfield, California, United States
Unnamed facility
Fair Oaks, California, United States
Unnamed facility
Fresno, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Boynton Beach, Florida, United States
...and 20 more locations