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CTRI Number  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)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Dr Gursimran Kaur  
Designation  Medical Monitor 
Affiliation  JSS Medical Research India Private Limited 
Address  6th Floor, Tower B, Vatika Mindscapes, Plot 12/2, Sector 27D

Faridabad
HARYANA
121003
India 
Phone  919899443314  
Fax  9101296613520  
Email  gursimran.kaur@jssresearch.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shariq Anwar  
Designation  Head- Operations  
Affiliation  JSS Medical Research India Private Limited 
Address  6th Floor, Tower B, Vatika Mindscapes, Plot 12/2, Sector 27D

Faridabad
HARYANA
121003
India 
Phone  919810979215  
Fax  9101296613520  
Email  shariq.anwar@jssresearch.com  
 
Source of Monetary or Material Support  
NovaLead Pharma Private Limited Anaahat, Plot No. 5, Ram Indu Park, S. No. 131/1b/2/11, Baner Road, Pune 411 045, INDIA  
 
Primary Sponsor  
Name  NovaLead Pharma Private Limited 
Address  Anaahat, Plot No. 5, Ram Indu Park, S. No. 131/1b/2/11, Baner Road,Pune 411045, INDIA  
Type of Sponsor  Other [Pharmaceutical Research & Development -Indian] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 35  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajesh Kesavan  Apollo Hospitals  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 
09428016850

ghrathod@gmail.com 
Dr Unnikrishnan Ambika Gopalakrishnan  Chellaram Diabetes Institute  Room No.53, 1st Floor Lalani Quantum, Pune-Bangalore Highway, Bavdhan Budruk-411021
Pune
MAHARASHTRA 
9689287337

unnikrishnanag@gmail.com 
Dr Mohammad Asif Haji Pyare Saheb Qureshi  Crescent Hospital and Heart Centre  Room No. G14, Department of Diabetology, Near Lokmat Square, Dhantoli-440012
Nagpur
MAHARASHTRA 
9226151571

drmaq@rediffmail.com 
Dr Manisha Satish Deshmukh  Deenanath Mangeshkar Hospital and Research Centre  Annexe building, Ground Floor, Wound Healing Centre Mahte Bridge Erandwane- 411004
Pune
MAHARASHTRA 
9823129387

mandeshmukh@rediffmail.com 
Dr Shobit Shakya  Dr. Ram Manohar Lohia Institute of Medical Sciences  Vibuti Khand, Gomti Nagar, Lucknow-226010
Lucknow
UTTAR PRADESH 
09935221759

shakya.shobhit@gmail.com 
Dr Sudhir Bhamre  Dr. Vasantrao Pawar Medical College, Hospital & Research  Dr. Vasantrao Pawar Medical College, Hospital & Research Centre Adgaon, Nashik
Nashik
MAHARASHTRA 
09423961936

Sudhir_bhamre@yahoo.com 
Dr Srikanth Kongara  Endolife Speciality Hospitals Pvt Ltd  D.No:12-12-94, Old Club Road, Kothapet, Guntur – 522 001, Andhra Pradesh, India.
Guntur
ANDHRA PRADESH 
09849945577

srikanthendo@gmail.com 
Dr Prathvi Shetty  Father Muller College and Hospital  Father Muller Road, Kankanady, Mangalore, DK, Karnataka- 575002
Dakshina Kannada
KARNATAKA 
09886839423

prathviz@gmail.com 
Dr KN Nagabhushan   Fortis Hospital Limited   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 
09845305728

drjagannathbhoomi@gmail.com 
Dr Sachin Arsule  Sujata Birla Hospital & Medical Research Center  Opposite Bytco College, Nashik Pune Highway, Nashik Road, Nashik 422101
Nashik
MAHARASHTRA 
08007744221

sachinarsule17@gmail.com 
Dr Mamidala Venkata Rama Mohan  Vijay Super Speciality Hospital  Ground Floor, Room No-4, 16-II/41 A, Raghava Cine Complex Road, Pogathota, Nellore, Andhra Pradesh- 524001, India
Nellore
ANDHRA PRADESH 
9490463301

rammohanmddm@gmail.com 
Dr Y Sadasivarao  Yalamanchi Hospital  D. No. 29-7-44, Venkataratnam Street, Suryaraopet, Vijayawada-52002, Andhra Pradesh
Krishna
ANDHRA PRADESH 
09848132230

drsada@yahoo.com 
Dr Laxmana Sastry   Yashoda Hospitals  Room No: 138, OPD, First Floor, Department of General Surgery, No. 18, Behind Harihara Kalabhavan, S.P. Road, Secunderabad-500003
Hyderabad
TELANGANA 
9849054696

glaxmanasastry@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 36  
Name of Committee  Approval Status 
Dr. Vasantrao Pawar Medical College, IEC  Approved 
Ethics Committee SP Medical College and A.G. Hospitals  Approved 
Ethics Committee, Crescent Hospital  Approved 
Ethics committee, Chellaram Diabetes Institute  Approved 
Ethics Committee, Indira Gandhi Govt Medical College and Hospital,  Submittted/Under Review 
Ethics Committee, MS Ramaiah Medical College & Hospital  Approved 
Ethics Committee, Prof. M Vishwanathan Diabetes Research Centre  Approved 
Father Muller Institutional Ethics Committee  Approved 
Fortis Hospital Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee Dr. Ram Manohar Lohia Institute of Medical Sciences  Approved 
Institutional Ethics Committee Endolife Speciality Hospital   Approved 
Institutional Ethics Committee NKP Salve Institute of Medical Sciences & Lata Mangeshkar Hospital  Approved 
Institutional Ethics Committee of B J Government Medical College and Sassoon General Hospital  Submittted/Under Review 
Institutional Ethics Committee of Madras, Diabetes Research Foundation  Approved 
Institutional Ethics Committee Sri Siddhartha Medical College  Approved 
Institutional Ethics Committee, Department of research, Deenanath Mangeshkar Hospital & Research Centre  Approved 
Institutional Ethics Committee, King George Hospital  Approved 
Institutional Ethics Committee, King George Hospital  Approved 
Institutional Ethics Committee, Maharaja Agrasen Hospital  Approved 
Institutional Ethics Committee, Poona Medical Research Foundation-Ruby Hall  Approved 
Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research  Approved 
Institutional Ethics Committee, Sapthagiri Institute of Medical Sciences & Research Centre  Approved 
Institutional Ethics Committee, Sri Ramachandra University, Chennai  Approved 
Institutional Ethics Committee, Yashoda Academy of Medical Education and Research, Yasshoda Hospitals  Submittted/Under Review 
Institutional Ethics Committee,Gandhi Medical College   Approved 
Institutional Ethics Committee-Clinical Studies, Apollo Hospitals Enterprise Ltd, Chennai  Approved 
KIMS Ethics Committee, Krishna Institute of Medical Sciences  Submittted/Under Review 
MGM Ethics Committee for research on human subjects (MGM-ECRHS).  Approved 
Noble Hospital Institutional Ethics Committee  Approved 
Rajalakshmi Hospital Institutional Ethics Committee  Approved 
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" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/11/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
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 
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