This is a Phase I, double blind, randomized, placebo-controlled study that will enroll approximately 50 adult subjects with Type 1 or Type 2 diabetes mellitus and chronic, diabetic foot ulcers. The study will be conducted at approximately 12 investigational sites in the United States.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
50
Incidence of clinically significant hypotension.
Incidence of clinically significant ulcer infection defined by increased discharge and malodorous exudates from the ulcer, fever, and a white blood cell (WBC) count of >10,000/uL
Development of anti telbermin antibodies
Incidence of adverse events
Percent reduction in total ulcer surface area.
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