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
Clinical Trials
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Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil
The purpose of this study is to evaluate the clinical effect of esmolol treatment on cardiac function and electrophysiology; to assess the effects of esmolol treatment on serum adrenergic ...
Pilot Study: Echocardiographic and Hemodynamic Effects of Esmolol in Septic Shock Patients
After initial hemodynamic stabilization, 36 septic shock patients with heart rate > of 90 bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) more than 65 mmHg will b...
Esmolol Infusion During Laminectomy: Effect on Quality of Recovery
The purpose of this study is to evaluate the effects of esmolol, a drug which is commonly administered during surgery to help control blood pressure and heart rate, on postoperative pain l...
This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients undergoing cardiac surgery to study the additive cardiac protection of this therapeutic strategy...
PubMed Articles
Esmolol may attenuate the sympathetic response to pain and reduce postoperative opioid consumption. It is not clear whether esmolol has an analgesic effect per se.
Esmolol is an ultrashort β-1 receptor antagonist. Recent studies suggest a role for esmolol in pain response modulation. The authors performed a meta-analysis to determine if the intraoperative use o...
Challenges facing cardiovascular imaging necessitate innovation of better radiopharmaceuticals to augment or replace the existing ones. This research assesses the ability and competency of radioiodina...
Rapid increases in desflurane concentration can transiently increase the heart rate (HR). Esmolol possesses a high β1-adrenoceptor selectivity and a short duration of action. This preliminary study a...
Esmolol acutely alters oxygen supply-demand balance in exercising muscles of healthy humans.
Beta-adrenoreceptor antagonists (β blockers) reduce systemic O delivery and blood pressure (BP) during exercise, but the subsequent effects on O extraction within the active limb muscles are unknown....
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