At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in Treating Diabetic Foot Ulcers
In Brief
A Phase 3 clinical trial evaluating Esmolol Hydrochloride, Only Standard of Care, and 1 other intervention for Diabetic Foot Ulcer. Completed, enrolled 176 participants across 14 sites.
Detailed Summary
The purpose of the current Study is to determine the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU). In addition, Study is designed to investigate the safety of Galnobax® vehicle for establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU. The study is being conducted in 350 subjects being recruited in about 30 centers in India.
Study Details
Timeline
Interventions
Galnobax-14% gel application along with Standard of Care
Only Standard of Care treatment
Vehicle gel application along with Standard of Care