This is a Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of three different doses of topically applied telbermin in subjects ≥ 18 years old with diabetic foot ulcers. Approximately 160 adult subjects with Type 1 or Type 2 diabetes mellitus will be enrolled at approximately 40 investigational sites in the United States and Canada.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
170
Skin re-epithelialization without drainage or dressing requirements
Time frame: 12 weeks
Complete closure of the study ulcer
Time frame: 24 weeks
Durability of closure
Time frame: Time to recurrence
Change and percent change in ulcer surface area
Time frame: 12 and 24 weeks
Number of debridements performed
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.