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Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT03998436
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Novalead Pharma Private Limited

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: Esmolol Hydrochloride Other: Only Standard of Care Other: Vehicle Gel Phase 3

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.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Galnobax® 14% gel plus SoC
Galnobax 14% gel along with Standard of Care (SoC) will be administered twice daily (150 subjects)
Drug: Esmolol Hydrochloride
Galnobax-14% gel application along with Standard of Care
Other Name: Galnobax

Sham Comparator: SoC Only
Only Standard of Care will be administered twice daily (150 subjects)
Other: Only Standard of Care
Only Standard of Care treatment

Placebo Comparator: Vehicle plus SoC
Vehicle gel along with Standard of Care (SoC) will be administered twice daily (50 subjects)
Other: Vehicle Gel
Vehicle gel application along with Standard of Care




Primary Outcome Measures :
  1. Proportion of Subjects achieving Target Ulcer Closure within 12-week Treatment Phase, as assessed by blinded Investigator [ Time Frame: 12-weeks ]
    Primary efficacy endpoint


Secondary Outcome Measures :
  1. Time to Target Ulcer Closure during the 12-week Treatment Phase, as assessed by the blinded Investigator. [ Time Frame: 12-weeks ]
    Secondary efficacy endpoint

  2. Proportion of Subjects achieving Target Ulcer Closure till End of Study, as assessed by the blinded Investigator. [ Time Frame: 24-weeks ]
    Secondary efficacy endpoint


Other Outcome Measures:
  1. Proportion of Subjects with treatment emergent adverse events (TEAEs) [ Time Frame: 24-weeks ]
    Safety endpoint

  2. Proportion of Subjects with events related to the local wound assessment of Target Ulcer in Vehicle plus Standard of Care group. [ Time Frame: 24-weeks ]
    Safety endpoint



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. Subjects, male or female, aged 18 to 75 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
  2. Subject has glycosylated hemoglobin, HbA1C, ≤ 12%
  3. Subject with diagnosis of neuropathic foot ulcer by 10g monofilament test
  4. Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.3
  5. Presence of at least one DFU that meets all of the following criteria:

    1. A full-thickness ulcer of Grade A1 as per Texas classification system;
    2. Ulcer is located below or up to 5 cm above the malleoli (excluding ulcers between the toes);
    3. Ulcer size (area) is ≥ 2 cm2 and ≤ 15 cm2 (post-debridement);
    4. There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post-debridement;
    5. No exposed bone, tendon, muscle, ligament or joint capsule, and no tunneling, undermining, or sinus tracts;
    6. Unresponsive to ulcer care and open for at least 6 weeks at the time of the Screening Visit;
    7. Ulcer is non-infected as determined by clinical assessment and complete hemogram;
    8. Ulcer has a clean, granulating base free of adherent slough to the greatest extent possible as per Investigator;
    9. Ulcer area reduction < 30% from the Screening Visit to Baseline visit
  6. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Investigator
  7. 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
  8. 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
  9. A Subject or LAR agrees to sign informed consent form and allow audio visual recording of consent, if applicable

Exclusion Criteria:

  1. Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis
  2. Subjects with more than three ulcers below knee
  3. Subjects with Target Ulcer requiring off-loading that cannot be effectively off-loaded; or unable to tolerate the off-loading method
  4. 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
  5. Ulcer, about which the Investigator is suspicious for cancer
  6. Subjects with a gangrenous or ischemic ulcer
  7. Subject with ulcer that in the opinion of the Investigator, may need amputation
  8. Subject with Target ulcer where wound measurement is not possible, such as ulcers between toes
  9. Body mass index (BMI) > 40 kg/m2
  10. Laboratory values at Screening of:

    1. Hemoglobin < 10.0 g/dL
    2. White Blood Cells (WBC) < 2.0 X 109 cells/L
    3. Liver function studies [Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)] > 3x the upper limit of normal
    4. Albumin < 2.5 g/dL
    5. eGFR < 25 mL/min
  11. Presence of any existing clinically significant medical condition(s) that, in the opinion of the Investigator, could interfere with wound healing
  12. 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
  13. Subject with intolerance to β-blockers at any time in the past
  14. Has any other factor which may, in the opinion of the Investigator, compromise participation and/or follow-up in the Study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998436


Locations
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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   
Sponsors and Collaborators
Novalead Pharma Private Limited

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Responsible Party: Novalead Pharma Private Limited
ClinicalTrials.gov Identifier: NCT03998436     History of Changes
Other Study ID Numbers: NG-A16
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Esmolol
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs