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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.
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Diabetic Foot Ulcer
Esmolol hydrochloride, Esmolol hydrochloride, Esmolol hydrochloride, Placebo gel
Boston University Medical Center
Not yet recruiting
Novalead Pharma Private Limited
Published on BioPortfolio: 2014-07-23T21:09:23-0400
Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil
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Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...