A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI
Status:
Completed
Trial end date:
2019-07-26
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, placebo-controlled, multi-center study, in patients with
moderate to severe diabetic foot infection (DFI), that will be conducted in two parts. In
Part I, patients will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1
(Active to Placebo). In Part II, patients will be randomized in a 1:1 ratio (Active to
Placebo) based on the optimal dose demonstrated in Part I. Patients will be randomized to
receive either topical application of MBN-101 or topical application of vehicle, applied
directly to the target site, 3 times per week, for a minimum of 14 days and up to a maximum
of 21 days. All patients will also receive systemic antibiotic treatment.