NCT01113515

Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Novalead Pharma Private Limited · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an interventional, placebo-controlled, randomized, double-blinded, dose comparison, phase I/II study of Galnobax® in subjects with diabetic foot ulcers. Additionally the effect of dosage and frequency of application will also be studied . The total trial duration per subject is 25 weeks which comprises of 1 week for screening, 12 weeks of treatment and 12 weeks of follow-up.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	Esmolol hydrochloride
DRUG	Esmolol hydrochloride
DRUG	Esmolol hydrochloride
DRUG	Placebo gel

Timeline

• Start date: 2014-02-20
• Primary completion: 2015-06-27
• Completion: 2015-10-17
• First posted: 2010-04-30
• Last updated: 2024-05-20
• Results posted: 2024-05-20

Locations

5 sites across 3 countries: United States, India, Malaysia