At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 44 enrolled
Drug / intervention
Esmolol hydrochloride +3 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.
An Interventional, Placebo-Controlled, Randomized, Double-blinded Dose Comparison, Phase I/II Study to Determine the Safety and Efficacy of a New Gel Formulation of Esmolol Hydrochloride (Galnobax®) for the Treatment of Diabetic Foot Ulcer (DFU)
In Brief
A Phase 2 clinical trial evaluating Esmolol hydrochloride and Placebo gel for Diabetic Foot Ulcer. Completed, enrolled 44 participants across 5 sites in 3 countries.
Detailed Summary
The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU). The study will compare number and types of adverse events occured, rates of wound closure and percentage of wounds closed in Galnobax treated groups versus placebo group.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcer
CountriesIndia, Malaysia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartFeb 2014
Primary CompletionJun 2015
Study CompletionOct 2015
TodayJul 2026
First PostedApr 30, 2010
Enrollment StartFeb 20, 2014
Primary CompletionJun 27, 2015
Study CompletionOct 17, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.2 years ago
Interventions
Esmolol hydrochloridedrug
Esmolol hydrochloridedrug
Esmolol hydrochloridedrug
Placebo geldrug