- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03998436
Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers
August 25, 2023 updated by: Novalead Pharma Private Limited
A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in Treating Diabetic Foot Ulcers
The purpose of the current Study is to determine the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU).
In addition, Study is designed to investigate the safety of Galnobax® vehicle for establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU.
The study is being conducted in 350 subjects being recruited in about 30 centers in India.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The current study is a Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in Treating Diabetic Foot Ulcers.
The study evaluates the safety and effectiveness of Galnobax® plus Standard of Care versus only Standard of Care, in treating Diabetic Foot Ulcers (DFU).
In addition, Study is designed to investigate the safety of Galnobax® vehicle for establishing non-deleterious effects of Vehicle on wound healing in the Subjects with DFU.
Study Type
Interventional
Enrollment (Actual)
176
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chandigarh, India, 110012
- Post Graduate Institute of Medical Education and Research (PGIMER)
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New Delhi, India, 110026
- Maharaja Agrasen Hospital
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Andhra Pradesh
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Vijayawada, Andhra Pradesh, India, 520002
- Yalamanchi Hospita
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Karnataka
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Bangalore, Karnataka, India, 560054
- M.S. Ramaiah Medical College and Hospital
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Bangalore, Karnataka, India, 560090
- Sapthagiri Institute of Medical Sciences and Research Centre
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Bangalore, Karnataka, India, 560097
- Rajlaxmi Hospital
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Tumkūr, Karnataka, India, 572107
- Sri Siddhartha Medical College
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Maharashtra
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Nashik, Maharashtra, India, 422101
- Sujata Birla Hospital & Medical Research Center
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Pune, Maharashtra, India, 411021
- Chellaram Diabetes Institute
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Pune, Maharashtra, India, 411004
- Deenanath Mangeshkar Hospital and Research Center
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Tamilnadu
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Chennai, Tamilnadu, India, 600086
- Madras Diabetes Research Foundation
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Chennai, Tamilnadu, India, 600006
- Appollo Hospital
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Chennai, Tamilnadu, India, 600013
- M.V. Hospital for Diabetes Pvt Ltd
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Chennai, Tamilnadu, India, 600116
- Sri Ramachandra Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Subjects, male or female, aged 18 to 75 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
- Subject has glycosylated hemoglobin, HbA1C, ≤ 12%
- Subject with diagnosis of neuropathic foot ulcer by 10g monofilament test
- Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.3
Presence of at least one DFU that meets all of the following criteria:
- A full-thickness ulcer of Grade A1 as per Texas classification system;
- Ulcer is located below or up to 5 cm above the malleoli (excluding ulcers between the toes);
- Ulcer size (area) is ≥ 2 cm2 and ≤ 15 cm2 (post-debridement);
- There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post-debridement;
- No exposed bone, tendon, muscle, ligament or joint capsule, and no tunneling, undermining, or sinus tracts;
- Unresponsive to ulcer care and open for at least 6 weeks at the time of the Screening Visit;
- Ulcer is non-infected as determined by clinical assessment and complete hemogram;
- Ulcer has a clean, granulating base free of adherent slough to the greatest extent possible as per Investigator;
- Ulcer area reduction < 30% from the Screening Visit to Baseline visit
- Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Investigator
- Subject, if female of child-bearing potential, has a negative urine pregnancy test at Screening and willing to use acceptable methods of contraception (birth control pills, barriers) or abstinence throughout the Study
- Subject is able and willing to comply with Study procedures including the use of an off-loading device (as applicable for the location of the ulcer) and adhere to protocol during the Study in the opinion of Investigator
- A Subject or LAR agrees to sign informed consent form and allow audio visual recording of consent, if applicable
Exclusion Criteria:
- Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis
- Subjects with more than three ulcers below knee
- Subjects with Target Ulcer requiring off-loading that cannot be effectively off-loaded; or unable to tolerate the off-loading method
- Subject has ulcers caused by a disease other than diabetes, e.g., fungal ulcerations, malignant ulcerations, and ulcerations due to venous or arterial insufficiency, or due to hematological disorders, in the opinion of the Investigator
- Ulcer, about which the Investigator is suspicious for cancer
- Subjects with a gangrenous or ischemic ulcer
- Subject with ulcer that in the opinion of the Investigator, may need amputation
- Subject with Target ulcer where wound measurement is not possible, such as ulcers between toes
- Body mass index (BMI) > 40 kg/m2
Laboratory values at Screening of:
- Hemoglobin < 10.0 g/dL
- White Blood Cells (WBC) < 2.0 X 109 cells/L
- Liver function studies [Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)] > 3x the upper limit of normal
- Albumin < 2.5 g/dL
- eGFR < 25 mL/min
- Presence of any existing clinically significant medical condition(s) that, in the opinion of the Investigator, could interfere with wound healing
- Subject has received or is currently receiving or scheduled to receive any medication or therapies during the course of the Study that will modulate wound healing
- Subject with intolerance to β-blockers at any time in the past
- Has any other factor which may, in the opinion of the Investigator, compromise participation and/or follow-up in the Study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Galnobax® 14% gel plus SoC
Galnobax 14% gel along with Standard of Care (SoC) will be administered twice daily (150 subjects)
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Galnobax-14% gel application along with Standard of Care
Other Names:
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Sham Comparator: SoC Only
Only Standard of Care will be administered twice daily (150 subjects)
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Only Standard of Care treatment
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Placebo Comparator: Vehicle plus SoC
Vehicle gel along with Standard of Care (SoC) will be administered twice daily (50 subjects)
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Vehicle gel application along with Standard of Care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects Achieving Target Ulcer Closure Within 12-week Treatment Phase, as Assessed by Blinded Investigator
Time Frame: Wound closure assessed up to week 12 and confirmed by 2 visits 2 weeks apart; only participants with wound closure at or before Week 12 and who maintained closure after 4-weeks of follow-up reported
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Proportion of complete closure of wounds within 12-week treatment phase where Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements evaluated in two visits two weeks apart from first observation of closure.
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Wound closure assessed up to week 12 and confirmed by 2 visits 2 weeks apart; only participants with wound closure at or before Week 12 and who maintained closure after 4-weeks of follow-up reported
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects Achieving Target Ulcer Closure Till End of Study, as Assessed by the Blinded Investigator.
Time Frame: 24-weeks. The ulcers achieving complete closure till end of study
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Proportion of complete closure of wounds at 24-weeks or End of Study where Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements.
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24-weeks. The ulcers achieving complete closure till end of study
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects With Treatment Emergent Adverse Events (TEAEs)
Time Frame: 24-weeks
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Proportion of Treatment emergent adverse events (TEAEs) in all the groups
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24-weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ashu Rastogi, MD, Post Graduate Institute of Medical Education and Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 26, 2018
Primary Completion (Actual)
August 19, 2021
Study Completion (Actual)
December 6, 2021
Study Registration Dates
First Submitted
June 24, 2019
First Submitted That Met QC Criteria
June 25, 2019
First Posted (Actual)
June 26, 2019
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
August 25, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Diseases
- Diabetic Foot
- Foot Ulcer
- Ulcer
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Adrenergic beta-1 Receptor Antagonists
- Esmolol
Other Study ID Numbers
- NG-A16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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