CTRI

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CTRI Number

CTRI/2025/06/088289 [Registered on: 05/06/2025] Trial Registered Prospectively

Last Modified On:

12/05/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Single Arm Study

Public Title of Study

Study of esmolol hydrochloride topical gel in treating diabetic foot ulcer

Scientific Title of Study

Evaluation of safety and efficacy of topical esmolol hydrochloride gel in treating diabetic foot ulcer: a multicenter, prospective, open-label phase 4 study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
Ipca/ESMO/PIV-24, A00, V01, 09.04.2024	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Anil Pareek
Designation	President
Affiliation	Ipca Laboratories Limited
Address	Medical Affairs and Clinical Research department, Plot 142-AB, 2nd floor Kandivli Industrial Estate, Kandivli (West) Mumbai (Suburban) MAHARASHTRA 400067 India Kandivli Industrial Estate Kandivli West Mumbai MAHARASHTRA 400067 India
Phone	02266474641
Fax
Email	anil.pareek@ipca.com

Details of Contact Person
Scientific Query

Name	Dr Anil Pareek
Designation	President
Affiliation	Ipca Laboratories Limited
Address	Medical Affairs and Clinical Research department, Plot 142-AB, 2nd floor Kandivli Industrial Estate, Kandivli (West) Mumbai (Suburban) MAHARASHTRA 400067 India Kandivli Industrial Estate Kandivli West MAHARASHTRA 400067 India
Phone	02266474641
Fax
Email	anil.pareek@ipca.com

Details of Contact Person
Public Query

Name	Nitin Chandurkar
Designation	Senior Vice President
Affiliation	Ipca Laboratories Limited
Address	Medical Affairs and Clinical Research department, Plot 142-AB, 2nd floor Kandivli Industrial Estate, Kandivli (West) Mumbai (Suburban) MAHARASHTRA 400067 India Kandivli Industrial Estate Kandivli West Mumbai MAHARASHTRA 400067 India
Phone	02266474622
Fax
Email	nitin.chandurkar@ipca.com

Source of Monetary or Material Support

Ipca Laboratories Ltd. Plot No. 142-AB, Kandivli Industrial Estate, Kandivli (W) Mumbai-400067

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
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
Ipca Laboratories Limited	Plot No. 142-AB, Kandivli Industrial Estate, Kandivli (W) Mumbai-400067

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 48
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sampath Kumar Poral	Aarupadai Veedu Medical College & Hospital	Pondy-Cuddalore Main Road, Kirumampakkam, Puducherry-607403 Pondicherry PONDICHERRY	9486267863 skdrsampathkumar@gmail.com
Dr Prakash Kumar Sasmal	AIIMS, Bhubaneswar	AIIMS Bhubaneswar, Sijua, Patrapada, Dumduma, Odisha-751019 Khordha ORISSA	9438884255 drpksasmal@gmail.com
Dr Amritava Ghosh	All India Institute of Medical Sciences	Dept of Endocrinology and Metabolism, AIIMS GE Road, Tatibandh, Raipur-492099,Chhattisgarh Raipur CHHATTISGARH	9547108310 amritava_ghosh@yahoo.co.in
Dr Nitin Sherkar	All India Institute of Medical Sciences	Plot No. 2, Sector 20, MIHAN, Nagpur 441108 Nagpur MAHARASHTRA	9665223852 drnitinsherkar@gmail.com
Dr Preyander Singh Thakur	All India Institute of Medical Sciences	Changar Palasiyan, Noa, Bilaspur - 17400l Bilaspur HIMACHAL PRADESH	7807408966 preyander.thakur@gmail.com
Dr Anil Gomber	Apollo Spectra Hospital	3 Pusa Road Karol Bagh New Delhi 110005 Central DELHI	9810153157 gombermedicare@gmail.com
Dr Sadanand Nandihalli	Belgavi Institute of Medical Sciences	Dr B R Ambedkar Road, Belgavi-590001 Belgaum KARNATAKA	9738106971 drnsadanand@gmail.com
Dr Srikanth Kulkarni	BGS Global Institute of Medical Sciences	No. 67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore-560060, Karnataka Bangalore KARNATAKA	9980218989 drsrikanthresearch79@gmail.com
Dr Ashok Damir	BLK-Max Superspeciality Hospital	Pusa Road, New Delhi-110005 Central DELHI	9810262600 drashok.damir@gmail.com
Dr Unnikirishnan AG	Chellaram Diabetes Institute	1st floor, Lalani quantum, Pune-Bangalore NH-4, Bavdhan, pune-411021 Pune MAHARASHTRA	9689287337 uagcdi@cdi.org.in
DrFelix Jebasingh K	Christian Medical College	810, Dept of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore, Tamil Nadu Vellore TAMIL NADU	80984697771 felixjebasingh@cmcvellore.ac.in
Dr Vinoth S	Clinical Trial and Training Center, Mahatma Gandhi Medical College and Research Center	45, Pondy Cuddalore, ECR Main Road, Pillayarkuppam, Puducherry 607402 Pondicherry PONDICHERRY	9443667373 vinoths@mgmcri.ac.in
Dr Arindam Ray	College of Medicine and Sagore Dutta Hospital	578 B T Road, Kamarhati, Kolkata - 700058 Kolkata WEST BENGAL	9477058636 rayarindam09@gmail.com
Dr K Arun Karthik	Diacare Diabetes Specialties Center	92, Sree Narayana Guru Rd, Saibaba Colony, Coimbatore 641011, Tamil Nadu Coimbatore TAMIL NADU	9894724752 drarunkarthik@yahoo.com
Dr Nikita Doshi	Doshis Diabetes and Endocrine Center	Behind Tourist Hotel, New Shahupuri, Kolhapur-416001 Kolhapur MAHARASHTRA	9673990305 doshiendocrineclinic@gmail.com
Dr Rajesh Kesvan	Dr RK Diabetic Foot and Podiatry Institute and Rakesh Jhunjhunwala Amputation Preventaion Center	Jayanthinagar Ext, off 200 feet road, Kolathur Chennai-600099 Chennai TAMIL NADU	9962400066 rajkesavdr@gmail.com
Dr Sudhir Dnyandeo Bhamare	Dr Vasantrao Pawar Medical College Hospital and Research Centre	Adgaon Nashik-422003 Nashik MAHARASHTRA	9823079792 sudhir_bhamre@yahoo.com
Dr Prathvi Shetty	Father Muller Medical College and Hospital	Father Muller Road, Kankanady, Mangalore-575002 Dakshina Kannada KARNATAKA	9886839423 prathviz@fathermuller.in
Dr Pratha Ramani	Government General Hospital, Government Medical College	Cantonment, Vizianagaram-535003, Andhra Pradesh Vizianagaram ANDHRA PRADESH	9848199301 drpramaniresearch@gmail.com
Dr Kethavath Sunil Naik	Government Medical College & General Hospital	Srikakulam-532001,Andhra Pradesh Srikakulam ANDHRA PRADESH	9440828299 drsunilnaikggh@gmail.com
Dr Gauthaman Chinnathambi Somanathan	Government Medical College & Hospital	Omandurar, Government Estate, Chennai-600 002, Tamil Nadu Chennai TAMIL NADU	9444343156 kirangautham@yahoo.com
Dr Digant Anilbhai Patel	Govt. Medical College & SSG Hospital	OPD-4, First Floor, Dept of General Surgery, Jail Road, Vadodara-390001, Gujarat Vadodara GUJARAT	9687600210 drsaidap@gmail.com
Dr Sanjay Agarwal	Grant Medical Foundation Ruby Hall Clinic	40, sassoon road, Pune -411001 Pune MAHARASHTRA	9822091220 sanjayagarwal.trial@gmail.com
Dr Ghanshyam Goyal	ILS Hospital	DD-6, Sector-1 Saltlake city, Kolkata -700064 Kolkata WEST BENGAL	9830400450 drgsgoyal@hotmail.com
Dr Abhishek M Karmalkar	Imperial Multi Specialty Hospital	Pingle Pride, near Radha Swami Ashram, Chikhali, Pune-411062 Pune MAHARASHTRA	9226083516 akarmalkar068@gmail.com
Dr Pranab Kumar Sahana	Institute of Post Graduate Medical Education and Research and SSKM Hospital	Department of Endocrinology, 244, AJC Bose road, Kolkata -700020 Kolkata WEST BENGAL	9231523624 pranabsahana@gmail.com
Dr Krishnamurthy H A	K R Hospital Mysore Medical College and Research Institute	Department of General Medicine Mysore -570001 Mysore KARNATAKA	9880668121 kmha79@gmail.com
Dr Pradeep Chopra	Karnataka Institute of Endocrinology and Research	Metro Station, Near Swami Vivekananda Road, Binnamangala, Stage l, Indira Nagar Bangalore KARNATAKA	7338464844 chopradeep@gmail.com
Dr Narendranadh Meda	KIMS Hospital	Minister Road Krishna Nagar Colony, Ramgopalpet, Begumpet, Hyderabad TELANGANA	9550483143 narenmeda@gmail.com
Dr B Vivekanand	King George Hospital	Department of Endocrinology, Andhra Medical college, Maharanipeta, Visakhapatanam -530002 Visakhapatnam ANDHRA PRADESH	9440514756 drvivek78@gmail.com
Dr A Jawahar	Kovai Diabetes Speciality Centre & Hospital	15 Vivekananda road, Ram Nagar, Coimbatore 641009 Coimbatore TAMIL NADU	9842231577 drjawahar.kdsch@gmail.com
Dr Manojit Ketan Mukhopadhyay	Life Line Diagnostic Center cum Nursing Home	4A, wood street, Kolkata-700016, Kolkata WEST BENGAL	9830203242 mkmukhopadhyay@yahoo.co.in
Dr Manisha Deshmukh	LMMFS Deenanath Mangeshkar Hospital and Research Center	Erandwane, Pune -411004 Pune MAHARASHTRA	9823129387 mandeshmukh@rediffmail.com
Dr Minakshi Gadahire	Lokmanya Tilak Municipal Medical College & Hospital	Dr. Babasaheb Ambedkar Marg, Sion, East, Mumbai 400022 Mumbai MAHARASHTRA	9820556928 gadhireminakshi@yahoo.in
Dr Minakshi Gadahire	Lokmanya Tilak Municipal Medical College & Hospital	Dr Babasaheb Ambedkar Marg, Sion, East, Mumbai 400022 Mumbai MAHARASHTRA	9820556928 gadhireminakshi@yahoo.in
Dr G Senthil	M V Hospital for Diabetes Private Ltd.	No 4 Main road, Royapuram, Chennai -600013 Chennai TAMIL NADU	44-2595491315 senaakee@gmail.com
Dr Deepak Bhosale	MGM Medical College and Hospital	N 6 Cidco, Chhatrapati Sambhaji Nagar Aurangabad MAHARASHTRA	7770087870 drdeepakbhosle.mgmmcha@gmail.com
Dr Arjun Baidya	Nil Ratan Sircar Medical College and Hospital	Department of Endocrinology,138, A.J.C Bose, kolkata -700014 Kolkata WEST BENGAL	9433154618 arjun.baidya@gmail.com
Dr Pratik Satyajit Wadhokar	Pawana Hospital	gate no 167, Urse, Parandwadi Rd, Somatane Phata, Pune-410506 Pune MAHARASHTRA	9860992755 pratikwadhokar08@gmail.com
Dr Ashu Rastogi	Post Graduate Institute of Medical Education and Research	Room 16, Ground Floor, Department of Endocrinology, PGI, Sector 12, Chandigarh -160012 Chandigarh CHANDIGARH	01722754756 rastogi.ashu@pgimer.nic.in
Dr Debmalya Sanyal	Rabindranath Tagore International Institute of Cardiac Sciences	124 Mukundapur, EM Bypass, Kolkata-700099 Kolkata WEST BENGAL	9830118388 drdebmalyasanyal@gmail.com
Dr S Ranjith Pratap	Rajiv Gandhi Government General Hospital	Poonamalle High Road, 3 Grand Western trunk road, Near Chennai Central, Chennai-600003 Chennai TAMIL NADU	9003272665 drranjith.rgghcr@gmail.com
Dr Gyan Chand	Sanjay Gandhi Post Graduate Institute of Medical Sciences	Department of Endocrine Surgery, Raebareli road, Lucknow -226014 Lucknow UTTAR PRADESH	9451546353 drgyanchandpgi@gmail.com
Dr Madhusudan C	Sapthagiri Institute of Medical Sciences and Research Center	Department of General Medicine 15, Chikkasandra, Hesarghatta main road Bangalore -560090 Bangalore KARNATAKA	9620158585 madhu85anu@gmail.com
Dr Sachin Ashok Arsule	Shree Sidhivinayak Maternity and Nursing Home	Unity Campus, Opp KTHM college, Gangapur Road Nashik-422002 Nashik MAHARASHTRA	8007744221 sachinarsule17@gmail.com
Dr Sinu Jayaprasad	Sree Utharadam Thirunal Hospital	Pattom Palace Pattom PO, Trivandrum-695004 Thiruvananthapuram KERALA	8281478192 drsinujp@gmail.com
Dr RB Sudagar Singh	Sri Ramchandra Hospital	Department of Medicine, Sri Ramchandra Hospital, Porur, Chennai-600116 Chennai TAMIL NADU	9003178899 drsingh7071@gmail.com
Dr Bahar Kulkarni	Sushrut Hospital	Department of Surgery, OPD no 1, Kothrud, Pune 411038 Pune MAHARASHTRA	020-35320000 drbahar.kulkarni96@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 48
Name of Committee	Approval Status
ACE Independent Ethics Committee	Approved
Chellaram Diabetes Institute Ethics Committee	Approved
College of Medicine and Sagore dutta Hospital	Submittted/Under Review
Dr RK Diabetic Foot and Podiatry Institute	Approved
Ethics Committee for Clinical Trial	Approved
Ethics Committee For Human Subject Research	Approved
Ethics Committee Sanjeevan Hospital	Approved
Father Muller Institutional ethics Committee	Approved
IEC BGS Global Institute	Approved
IEC Deenanath Mangeshkar Hospital	Approved
IEC Dr vasantrao Pawar medical College	Approved
IEC Government Medical College Omandurar	Approved
IEC King George Hospital	Approved
IEC Lifeline Diagnostic Center cum Nursing Home	Approved
IEC Mysore Medical College and Research Institute and Associated Hospitals	Approved
IEC, AIIMS, Bhubaneswar	Approved
ILS Hospital Ethics Committee	Approved
Imperial Ethics Committee	Submittted/Under Review
Institutional Ethics Committee Belgavi	Approved
Institutional Ethics Committee Clinical Studies	Approved
Institutional Ethics Committee Clinical Trials	Approved
Institutional Ethics Committee Dr B L Kapur Memorial Hospital	Approved
Institutional Ethics Committee for Human Research Medical College & SSG Hospital, Baroda	Approved
Institutional Ethics Committee Kovai Diabetes Speciality Centre and Hospital	Approved
Institutional Ethics Committee Lokmanya Tilak	Approved
Institutional Ethics Committee Madras Medical College	Approved
Institutional Ethics Committee Medanta Lucknow	Submittted/Under Review
Institutional Ethics Committee MV Diabetes Research Centre	Approved
Institutional Ethics Committee NRS Medical College	Approved
Institutional Ethics Committee PGIMER	Approved
Institutional Ethics Committee SRIHER	Approved
Institutional Ethics Committee, Government General Hospital	Approved
Institutional Ethics Committee, AIIMS, Raipur	Approved
Institutional Ethics Committee, Government Medical College	Approved
Institutional Ethics Committee, Sanjay Gandhi Postgraduate Institute of Medical Sciences	Approved
Institutional Human Ethics Committee MGM Medical College Research Institute	Approved
Institutional Human Ethics Committee, Aarupadai Veedu Medical College & Hospital	Approved
Institutional Review Board Office of Research Christian Medical College	Approved
IPGMEandR research Oversight Committee	Approved
KIMS Ethics Committee	Approved
Lifepoint Research Ethics Committee	Approved
MGM Ethics Committee For Research On Human Subjects	Approved
NHRTIICS Ethics Committee	Approved
Poona Medical Research Foundation	Submittted/Under Review
Research Ethics Committee	Approved
Sapthagiri Hospital Institutional Ethics Committee	Approved
Shree Siddhivinayak hospital Ethics Committee	Submittted/Under Review
Zenith Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E116\|\|Type 2 diabetes mellitus with other specified complications,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Esmolol Hydrochloride Gel 14% w/w	All enrolled trial participants will be instructed to apply the gel twice daily on wound surface area for a treatment duration of 12 weeks or until ulcer closure, whichever is earlier. The amount of gel to be applied will vary depending upon the area and depth of the ulcer as advised by the physician (about 0.6 cm length of gel per cm2 of the surface area of ulcer). One should apply the gel to the ulcer in such a way that a uniform layer of the gel forms over the wound surface.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	1. Subjects with HbA1c less than or equal to 12 percent 2. Type 1 or Type 2 diabetes patient undergoing therapy for glycemic control 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 greater than or equal to 0.65 5. Ulcer is uninfected or mildly infected as per IWGDF or IDSA guidelines 6. Unresponsive to ulcer care and open for at least 6 weeks at the time of the Screening Visit 7. Ulcer is located below or up to 5cm above the malleoli excluding ulcers between the toes 8. Ulcer size is greater than or equal to 1 cm2 and less than or equal to 20 cm2 post debridement 9. There is a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post debridement 10. No exposed bone, tendon, muscle, ligament or joint capsule, and no tunneling, undermining, or sinus tracts 11. Ulcer area reduction less than 20 percent from the Screening Visit to Baseline visit 12.Subject is able and willing to comply with study procedures and adhere to protocol during the study in the opinion of Investigator 13. A Subject or LAR agrees to sign informed consent form

ExclusionCriteria

Details

1. Deeply infected ulcers with exposed bone or associated with osteomyelitis
2. Subjects who are systemically well and metabolically stable but also has 1 or more ulcer characteristics of cellulitis extending more than 2cm or lymphangitic streaking, or spread beneath the superficial fascia or deep tissue abscess or gangrene in the opinion of the Investigator
3. Infection in patient with systemic toxicity or metabolic instability
4. Subjects showing inflammatory response of the skin caused by trauma, gout, acute charcot neuro-osteo arthropathy, fracture, thrombosis or venous stasis
5. Hemoglobin less than 8 gram per deciliter
6. White Blood Cells less than 2000 per microliter
7. Albumin less than 2.5 gram per deciliter
8. e-GFR less than 30 ml per min per 1.73m2 of body surface area
9. Subject has ulcers caused by a disease other than diabetes, for example fungal ulcerations, malignant ulcerations, and ulcerations due to venous or arterial insufficiency, or due to hematological disorders, in the opinion of the Investigator
10.Presence of any existing clinically significant medical conditions that, in the opinion of the Investigator, could interfere with wound healing
11. Patient diagnosed with HIV or cancer undergoing chemotherapy or using immunosuppressant drugs except inhalers for respiratory disorders and colchicine
12. Subjects who have received therapy for the treatment of diabetic foot in last 2 weeks
13. Subject with intolerance to beta blockers at any time in the past
14. Patients on another investigational agent or device or therapy or participated in a clinical trial within the last 4 weeks prior to enrollment
15. Pregnant or lactating women or women of childbearing potential not practicing contraception
16. Has any other factor which may, in the opinion of the Investigator, compromise participation or follow up in the Study

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Other

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Assess safety and tolerability of Esmolol Hydrochloride gel in diabetic foot ulcer subjects	Baseline to End of Study

Secondary Outcome

Outcome	TimePoints
Assess efficacy of Esmolol Hydrochloride gel in diabetic foot ulcer subjects in terms of proportion of subjects achieving Target Ulcer closure within 12 week treatment period and assess the time to Target Ulcer closure within 12 week treatment period	Baseline to week 12

Target Sample Size

Total Sample Size="400"
Sample Size from India="400"
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

N/A

Date of First Enrollment (India)

15/07/2025

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="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This is a multicenter, prospective, open-label study. Type 1 or Type 2 Diabetes patients with unhealed diabetic foot ulcer for at least 6 weeks will be screened for the study. At least four hundred patients satisfying the eligibility criteria will be enrolled and treated for the next 12 weeks or until the closure of ulcer whichever is earlier. Upon confirmation of eligibility, patient will be enrolled in the study. Thereafter, twice daily application of the investigational product (Esmolol Hydrochloride Topical Gel 14% w/w) will be initiated.

The study will have a screening visit, baseline visit, treatment visits on week 1, week 2, week 4, week 6 and week 8, and end of study visit (week 12).

Safety assessment will be based on clinically significant changes in laboratory parameters and incidence of adverse events.

Efficacy will be evaluated based on proportion of subjects achieving Target Ulcer closure during treatment period till end of study and time to Target Ulcer closure during the 12 week treatment period, as assessed by the investigator. Reduction in ulcer area from baseline to end of study will be recorded.