A clinical trial to study effect of new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU)
- Conditions
- Health Condition 1: null- Diabetic Foot Ulcer
- Registration Number
- CTRI/2013/07/003838
- Lead Sponsor
- ovalead Pharma Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Patients having single or up to two ulcers, minimum 4.0 cm apart, below knee ulcer of at least 4 weeks and maximum of 52 weeks duration which is a full thickness ulcer without exposure of bone, muscle, ligaments, or tendons
Ulcer should be clinically non-infected as determined by clinical examination and complete hemogram
Ulcer area (length x width) measurement between 1.5 square centimeter and 10 square centimeter, inclusive and post debridement ulcer area less than or equal to 12 square centimeter
Full-thickness ulcer of Grade 1 or Grade 2 as per Wagnerâ??s classification system
Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis
Patients with target limb cellulitis, ischemic or gangrenous ulcers in the opinion of the Investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy endpoint: <br/ ><br>Reduction in area and volume of ulcers <br/ ><br> <br/ ><br>Safety endpoint: <br/ ><br>Incidence of adverse events (AEs)Timepoint: Efficacy endpoint: <br/ ><br>Week 12 from baseline / wound closure which ever is earlier <br/ ><br> <br/ ><br>Safety endpoint: <br/ ><br>nd of follow up phase
- Secondary Outcome Measures
Name Time Method Efficacy endpoint: <br/ ><br>Time taken for healing and closure of wound in different groups <br/ ><br> <br/ ><br>Pharmacokinetic (PK) endpoint: <br/ ><br>Pharmacokinetic profile of Galnobax® in subset of patients suffering from DFU.Timepoint: Efficacy endpoint: <br/ ><br>From baseline <br/ ><br> <br/ ><br>Pharmacokinetic (PK)endpoint: <br/ ><br>Drug concentration in blood on Day 0, Week 1, Week 4, Week 12