Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
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)
Links
- Source: http://clinicaltrials.gov/show/NCT01113515
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:09:23-0400
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