At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 31 enrolled
Drug / intervention
Bisphosphocin Nu-3 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/IIa, Randomized Double Blind, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating Bisphosphocin Nu-3 and Placebo for Diabetic Foot Infections. Completed, enrolled 31 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Infections
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartApr 2016
First PostedApr 2016
Primary CompletionAug 2017
Study CompletionFeb 2018
TodayJul 2026
First PostedApr 14, 2016
Enrollment StartApr 1, 2016
Primary CompletionAug 1, 2017
Study CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.2 years ago
Interventions
Bisphosphocin Nu-3drug
Placebodrug