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

2014-07-23 21:09:23 | BioPortfolio

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.

Description

This is an interventional, placebo-controlled, randomized, double-blinded, dose comparison, phase I study of Galnobax® in subjects with diabetic foot ulcers. Additionally the effect of dosage and frequency of application upon time taken for the ulcer to heal and close will also be studied in the phase. The study will recruit 50 subjects of which 40 subjects in India and 10 subjects in USA. Out of 40 subjects in India, 16 willing subjects will be considered for pharmacokinetic as well as biomarker study of Galnobax. The total trial duration per subject is 25 weeks which comprises of 1 wek for screening, 12 weeks of treatment and 12 weeks of follow-up. There are four groups in the trial: three treatment groups and one placebo control group.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Diabetic Foot Ulcer

Intervention

Esmolol hydrochloride, Esmolol hydrochloride, Esmolol hydrochloride, Placebo gel

Location

Boston University Medical Center
Boston
Massachusetts
United States
02118

Status

Not yet recruiting

Source

Novalead Pharma Private Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:23-0400

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