Condition or disease | Intervention/treatment | Phase |
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Diabetic Foot Ulcer | Drug: Esmolol Hydrochloride Other: Only Standard of Care Other: Vehicle Gel | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 350 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Prospective, Multicenter, Randomized, Double-Blind, Parallel groups |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | The subject will be masked from the treatment by the Study Nurse (care giver) by using blinder during each treatment application. The site has two separate teams (blinded and unblinded) for masking. The unblinded investigator performs application of treatment during each treatment visit of subject to the site. |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | December 26, 2018 |
Estimated Primary Completion Date : | June 30, 2020 |
Estimated Study Completion Date : | October 30, 2020 |
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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Drug: Esmolol Hydrochloride
Galnobax-14% gel application along with Standard of Care
Other Name: Galnobax
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Sham Comparator: SoC Only
Only Standard of Care will be administered twice daily (150 subjects)
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Other: Only Standard of Care
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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Other: Vehicle Gel
Vehicle gel application along with Standard of Care
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presence of at least one DFU that meets all of the following criteria:
Exclusion Criteria:
Laboratory values at Screening of:
India | |
M.S. Ramaiah Medical College and Hospital | Recruiting |
Bangalore, Karnataka, India, 560054 | |
Contact: Sanjay Desai, MS 9845290575 scdesai@hotmail.com | |
Deenanath Mangeshkar Hospital and Research Center | Recruiting |
Pune, Maharashtra, India, 411004 | |
Contact: Manisha Deshmukh, MD 9823129387 mandeshmukh@rediffmail.com | |
Chellaram Diabetes Institute | Recruiting |
Pune, Maharashtra, India, 411021 | |
Contact: A G Unnikrishnan, MD 9689287337 unnikrishnanag@gmail.com | |
M.V. Hospital for Diabetes Pvt Ltd | Recruiting |
Chennai, Tamilnadu, India, 600013 | |
Contact: Vijay Viswanathan, M.D. 9840055535 drvijay@mvdiabetes.com | |
Madras Diabetes Research Foundation | Recruiting |
Chennai, Tamilnadu, India, 600086 | |
Contact: Muthu Ramu, F. Diab. 9840923632 tmcramu2000@yahoo.co.in | |
Sri Ramachandra Hospital | Recruiting |
Chennai, Tamilnadu, India, 600116 | |
Contact: Sudhagar Singh, MD 9003178899 drsingh7071@gmail.com | |
Post Graduate Institute of Medical Education and Research (PGIMER) | Recruiting |
Chandigarh, India, 110012 | |
Contact: Ashu Rastogi, MD 9781001046 ashuendo@gmail.com | |
Maharaja Agrasen Hospital | Recruiting |
New Delhi, India, 110026 | |
Contact: Deepak Khandelwal, MD 9968878561 khandelwalaiims@gmail.com |
Tracking Information | |||||
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First Submitted Date ICMJE | June 24, 2019 | ||||
First Posted Date ICMJE | June 26, 2019 | ||||
Last Update Posted Date | June 26, 2019 | ||||
Actual Study Start Date ICMJE | December 26, 2018 | ||||
Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Proportion of Subjects achieving Target Ulcer Closure within 12-week Treatment Phase, as assessed by blinded Investigator [ Time Frame: 12-weeks ] Primary efficacy endpoint
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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. | ||||
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 ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Prospective, Multicenter, Randomized, Double-Blind, Parallel groups Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: The subject will be masked from the treatment by the Study Nurse (care giver) by using blinder during each treatment application. The site has two separate teams (blinded and unblinded) for masking. The unblinded investigator performs application of treatment during each treatment visit of subject to the site. Primary Purpose: Treatment
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Condition ICMJE | Diabetic Foot Ulcer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
350 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | October 30, 2020 | ||||
Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | India | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03998436 | ||||
Other Study ID Numbers ICMJE | NG-A16 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Novalead Pharma Private Limited | ||||
Study Sponsor ICMJE | Novalead Pharma Private Limited | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Novalead Pharma Private Limited | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |