NCT03998436

Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Novalead Pharma Private Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The current study is 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. The study evaluates 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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	Esmolol Hydrochloride	Galnobax-14% gel application along with Standard of Care
OTHER	Only Standard of Care	Only Standard of Care treatment
OTHER	Vehicle Gel	Vehicle gel application along with Standard of Care

Timeline

• Start date: 2018-12-26
• Primary completion: 2021-08-19
• Completion: 2021-12-06
• First posted: 2019-06-26
• Last updated: 2023-09-22
• Results posted: 2023-09-22

Locations

14 sites across 1 country: India

Regulatory

• FDA-regulated drug study