Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel
cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized
to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with
either (A) daily application of a gentamicin-sponge, (B) daily application of a
placebo-sponge or (C) no-sponge, in the ratio 2:1:1.
Patients will be treated for approximately 28 days and return to the clinic weekly for safety
and efficacy assessments. After completing treatment, patients will return to the clinic for
scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.