Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus

Summary

Phase I/IIa, five cohort ascending dose with two dosing arms per cohort, study in Type I or II diabetes mellitus subjects with a chronic infected diabetic ulcer defined as having a DUSS score of 0 to 3 and DFI wound score of 1 to 3.

Timeline

Start

2016-04

Primary completion

2017-08

Completion

2018-02

Outcome

Missed primary endpoint

registry analysis (superiority test); 1% Bisphosphocin Nu-3 vs Placebo; p = 0.5152; Fisher Exact NCT02737722 ↗

registry analysis (superiority test); 2% Bisphosphocin Nu-3 vs Placebo; p = 1.0000; Fisher Exact NCT02737722 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bisphosphocin Nu-3	Small molecule	1 mg/ml	Topical
Subject	Bisphosphocin Nu-3	Small molecule	10 mg/ml	Topical
Subject	Bisphosphocin Nu-3	Small molecule	20 mg/ml	Topical
Subject	Bisphosphocin Nu-3	Small molecule	50 mg/ml	Topical
Subject	Bisphosphocin Nu-3	Small molecule	100 mg/ml	Topical

Indications

No indication recorded.