If approved, the trial will evaluate the safety and tolerability of increasing doses of Nu-3 when applied topically as well as collect data on the changes in the microbiology of the ulcer over the course of treatment.
The company said that the Phase I/IIa trial of Nu-3 is expected to be initiated early in 2015.
Lakewood-Amedex vice-president Product Development Paul DiTullio said: "This IND submission represents a major development milestone for our Bisphosphocin program.
"Our lead candidate, designated Nu-3, is the first in a novel class of synthetic broad spectrum antimicrobials that the Company is developing to address the growing unmet medical need in the antibiotic field.
"Bisphosphocins with their unique mechanism of action are particularly well suited for treating infected diabetic foot ulcers as these infections tend to be caused by both gram positive and gram negative bacteria and involve biofilm."
The company is focused on developing a broad portfolio of new-approach anti-infective products in the treatment of serious infectious diseases, improving patient outcomes and significantly reducing the threat posed by antibiotic-resistant bacterial strains like MRSA, VRE, NDM-1 and biofilm strains.