CTRI/2018/11/016295 [Registered on: 09/11/2018] Trial Registered Prospectively
Last Modified On:
04/11/2020
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A study to check the effects and safety of Galnobax gel in treating Diabetic Foot Ulcer.
Scientific Title of Study
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.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NG-A16, Version 1.0 dated 21 Jul 2017
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Department of Diabetic Foot Clinic,
Sindoori Block, Counter S10
Door No.21, Greams Lane, Off Greams Road-600006 Chennai TAMIL NADU
9360778800
rajkesavdr@gmail.com
Dr Kirankumar P Jadhav
B.J. G.M.C & Sassoon General Hospital
1st Floor, Department of Surgery,
Pune Sassoon Road, Somwar Peth-411001 Pune MAHARASHTRA
9823949126
drj.kirankumar@gmail.com
Dr Gunvant H Rathod
B.J. Medical College and Civil Hospital
Professor and Head of Surgery,
Office of the Medical Superintendent Civil Hospital,
B.J. Medical College and Civil Hospital,
Ahmedabad-380016
Ahmadabad GUJARAT
1st Floor, Department o Vascular Surgery.
154/9, Bannerghatta Road, Opposite IIM-B-560076, Bangalore KARNATAKA
9845396765
nagabhushan.kn@fortishealthcare.com
Dr Anil Kumar Darivemula
Gandhi Hospital
In-Patient Block, 2nd Floor, Department of General Medicine, Gandhi Hospital, Musheerabad, Secunderabad, Telangana-500003 Hyderabad TELANGANA
09440523902
anilddrmd@gmail.com
Dr Vishal Rupchand Nandagawali
Indira Ganshi Govt. Medical College and Hospital
First Floor (In front of Dean Room),
Surgery Department,
Indira Gandhi Govt Medical.
Nagpur MAHARASHTRA
9764132444
drvishal.nandagawali@gmail.com
Dr Arjuna Gera
King George Hospital
Research Room,1st floor, Rajendra Prasad Ward,
Department of Medicine, Maharanipeta,
Visakhapatnam-530002
Visakhapatnam ANDHRA PRADESH
09848197833
drgeraarjunaresearch@gmail.com
Dr Shiva Raju
Krishna Institute of Medical Sciences
Department of General Medicine, OPD, Door No. 1-8-31/1, Minister Road, Secunderabad-500003 Hyderabad TELANGANA
9848510401
info@kimshospital.com
Dr Sanjay C Desai
M.S. Ramaih Medical College and Hospital
Room No. 8, Department of Vascular and Endovascular Surgery.
M.S. Ramaih Nagar, MSRIT Post-560054 Bangalore KARNATAKA
9845290575
scdesai@hotmail.com
Dr Vijay Viswanathan
M.V. Hospital for Diabetes Private Limited
Out Patient Department, Consultation Room, Door No. 4 West Madha Church Street, Royapuram-600013 Chennai TAMIL NADU
9840055535
drvijay@mvdiabetes.com
Dr Muthu Ramu
Madras Diabetes Research Foundation
Department of Diabetology,
No. 4, Conran Smith Road, Gopalapuram-600086 Chennai TAMIL NADU
9840923632
tmcramu2000@yahoo.co.in
Dr Deepak Khandelwal
Maharaja Agrasen
Room: 08, Department of Endocrinology
West Punjab bagh- 110026 New Delhi DELHI
9968878561
khandelwalaiims@gmail.com
Dr Deepak Bhosle
Mahatma Gandhi Mission Medical College & Hospital
Clinical Research Unit, Department of Clinical Pharmacology & Therapeutics,
Mahatma Gandhi Mission Medical College & Hospital
N-6, CIDCO, Aurangabad-431003, Maharashtra
Aurangabad MAHARASHTRA
07770087870
drdeepakbhosle@gmail.com
Dr Murtuza Akhtar
NKP Salve Institute of Medical Sciences & Research Center
Digdoh Hills, Hingana Road, Nagpur-440019, Maharashtra, India Nagpur MAHARASHTRA
09823148808
murtazaakhtar27@gmail.com
Dr Reema Yuvraj Kashiva
Noble Hospital Private Limited
153, Magarpatta City Road, Hadapsar, Pune, Maharashtra-411013 Pune MAHARASHTRA
09922618286
dr.kashivareema@gmail.com
Dr Ashu Rastogi
Post Graduate Institute of Medical Education and Research (PGIMER)
Room no 26, Nehru Hospital, 4th floor, f block,
Sector 12, Chandigarh-110012 Chandigarh CHANDIGARH
9781001046
ashuendo@gmail.com
Dr Giri Raja KV
Rajalakshmi Hospital
Department of Clinical Research,
No: 21/1 Lakshmipura Main Road, Vidyranyapura Post, Bangalore- 560097
Bangalore KARNATAKA
09448039952
drgiriraja@gmail.com
Dr Sanjay Agarwal
Ruby Hall Clinic
Department of Diabetology
Main Building,
Ground Floor,
Cardiac OPD Medical Foundation, Ruby Hall Clinic, 40 Sassoon Road Pune MAHARASHTRA
9822091220
sanjayagarwal.trails@gmail.com
Dr RP Agrawal
S. P. Medical College
Diabetes Care and Research Centre, Sardar Patel Medical College, Bikaner-334003, Rajasthan, India Bikaner RAJASTHAN
01512202131
drrpagrawal@yahoo.co.in
Dr Sanjay Sukhdeo Kolte
Sahyadri Speciality Hospital
Room no 1002, Department of surgery,
Erandawane, Karve Road-411001 Pune MAHARASHTRA
9822009490
sanjaykolte@hotmail.com
Dr Madhusudan C
Sapthagiri Institute of Medical Sciences & Research Centre
No.15, Chikkasandra, Hesaraghatta, Main Road, Bengaluru-560090, India Bangalore KARNATAKA
09620158585
madhu85anu@gmail.com
Dr Ajay Yadav
Sir Ganga Ram Hospital
Room No. 1412,
Department of Endovascular Surgery,
Sir Ganga Ram Marg, Rajinder Nagar-110060 New Delhi DELHI
9717183355
ajay.vascular@gmail.com
Dr R B Sudhagar Singh
Sri Ramachandra Hospital
Room No: 12, Department of General Medicine.
Sri Ramachandra Hospital
No.1, Ramachandra Nagar
Porur-600116 Chennai TAMIL NADU
9003178899
drsingh7071@gmail.com
Dr Jagannath
Sri Siddhartha Medical College
Department of surgery,
Sri Siddhartha Medical College and Research Centre,
B. H. Road, Agalkote,
Tumkur, Karnataka- 572107, India
Tumkur KARNATAKA
Sahyadri Hospitals Ltd Ethics committee, Sahyadri clinical research and development center
Submittted/Under Review
Sir Ganga Ram Hospital Ethics Committee
Approved
Sujata Birla Hospital, Ethics Committee
Approved
The institutional Ethics Committee, B.J. Medical College & Civil Hospital
Approved
Vijaya Ethics Committee
Approved
Yalamanchi Hospital Ethics Committee.
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: E086||Diabetes mellitus due to underlying condition with other specified complications,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Only Standard of Care
Subjects in the Study will receive Standard of Care treatment twice daily during the 12-weeks of Treatment Phase or up to the Target Ulcer Closure, whichever is earlier.
Dose: Depends on the size of the wound
Frequency: Twice Daily
Route of Administration: Topical
Total Duration: 12 weeks
Intervention
Topical Galnobax gel (14% twice daily application) plus Standard of care
Subjects in the Study will receive treatment twice daily during the 12-weeks of Treatment Phase or up to the Target Ulcer Closure, whichever is earlier.
Dose: Depends on the size of the wound
Frequency: Twice Daily
Route of Administration: Topical
Total Duration: 12 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Subjects, male or female, aged 18 to 65 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:
a. A full-thickness ulcer of Grade A1 as per Texas classification system;
b. Ulcer size (area) is ≥ 2 cm2 and ≤ 15 cm2 (post-debridement);
c. No exposed bone, tendon, muscle, ligament or joint capsule, and no tunneling, undermining, or sinus tracts;
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
ExclusionCriteria
Details
Subjects will not be eligible for enrolment in the Study if they meet any of the exclusion criteria listed below:
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, 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: Hemoglobin < 10.0 g/dL, White Blood Cells (WBC) < 2.0 X 109 cells/L, Albumin < 2.5 g/dL, 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 medication or therapies during the course of the Study such as Immunosuppressants, Revascularization surgery, Growth factors, Hyperbaric oxygen therapy (HBOT), Negative pressure wound therapy (NPWT), Bioengineered tissue or skin substitutes, Topical steroids, Investigational drug(s) or therapies
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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of Subjects achieving Target Ulcer Closure within 12-week Treatment Phase, as assessed by blinded Investigator.
12 weeks
Secondary Outcome
Outcome
TimePoints
Time to Target Ulcer Closure during the 12-week Treatment Phase, as assessed by the blinded Investigator
12 weeks
Proportion of Subjects achieving Target Ulcer Closure till End of Study, as assessed by the blinded Investigator
24 weeks
Target Sample Size
Total Sample Size="350" Sample Size from India="350" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This study is a prospective, multicenter, randomized, double-Blind, phase 3 study to evaluate the safety and efficacy of a Gel Formulation of Galnobax® in treating Diabetic Foot Ulcers for 12 weeks in 350 patients and will be conducted in 21 centers in India from seven cities. The primary outcome will be proportion of subjects achieving target ulcer closure in 12-week treatment period and Secondary outcome will be time to target ulcer closure during the 12 weeks treatment and proportion of subjects achieving target ulcer closure till end of study assessed by blinded investigator