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CTRI Number  CTRI/2024/12/078006 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 20/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the efficacy of Topical Timolol based dressing versus Normal Saline dressing in the healing of chronic non-healing wounds 
Scientific Title of Study   Comparison of topical timolol versus conventional therapy for healing of chronic non-healing wounds- a randomized control trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Dhinesh S 
Designation  Junior resident 
Affiliation  JIPMER 
Address  Dr. Dhinesh S, Junior resident, Room no 1 Ward 37 Unit 4 Department of Surgery, JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  8220024722  
Fax    
Email  dhineshksd07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Balamourougan. K 
Designation  Additional professor 
Affiliation  JIPMER 
Address  Dr. Balamourougan.K, Additional Professor, Department of surgery, JIPMER.

Pondicherry
PONDICHERRY
605006
India 
Phone  9443617089  
Fax    
Email  drbalak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Dhinesh S  
Designation  Junior Resident  
Affiliation  JIPMER 
Address  Dr. Dhinesh S, DDR room no 37, Unit-4, Department of Surgery, JIPMER.

Pondicherry
PONDICHERRY
605006
India 
Phone  8220024722  
Fax    
Email  dhineshksd07@gmail.com  
 
Source of Monetary or Material Support  
JIPMER , Jipmer Campus Rd, Jipmer Campus, Puducherry, 605006 
 
Primary Sponsor  
Name  JIPMER 
Address  Jipmer Campus Rd, Jipmer Campus, Puducherry, 605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dhinesh S  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)  Department of Surgery, JIPMER, Jipmer Campus Rd, Jipmer Campus, Puducherry, 605006
Pondicherry
PONDICHERRY 		 8220024722

dhineshksd07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.5% Topical Timolol solution with 0.9% Normal saline  To each patient, one drop of 0.5% Timolol will be instilled every 2 cm² of wound edge in addition to Normal Saline based dressing. This will be done once a day for a period of 8 weeks or till the wound is completely healed,whichever comes first  
Comparator Agent  0.9 % Normal saline   Normal saline based dressing alone will be used for the patient. This will be done once a day for a period of 8 weeks or till the wound is completely healed,whichever comes first  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients above 18 years of age with chronic ulcers of more than 4 weeks duration and less than 1 year duration
2. Surface area between 0.5 cm2 and 100 cm2 (measured using the smartphone-based app -imito measure11). Ulcers with the largest surface area and longest duration meet the criteria in case of multiple ulcers 
 
ExclusionCriteria 
Details  1.Pressure ulcers
2. Patients with history of bradycardia (heart rate less than 60)
3. Patients with medically documented history of hypotension/orthostatic hypotension and/or symptomatic hypotension (systolic blood pressure below 90 and diastolic blood pressure less than 60).
4. Patients currently taking asthma or COPD medications
5. Patients having palpitations, syncope, dyspnea, and/or angina at rest
6. Ulcers with signs of active infection such as cellulitis, purulent exudate, osteomyelitis or exposed bones, tendon and fascia
7. Patients with known immunodeficiency
8. Patients with known chronic kidney or liver disease
9. Patients who received prior radiation or chemotherapy
10. Female patients who are pregnant.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the effect of topical timolol on wound healing in chronic non-healing ulcers measured in terms of percentage reduction in wound surface area over an 8 week period   At the time of initial presentation-day 1
At the end of 2,4,6 and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the pathological strength of granulation.   Over an 8 week period 
To assess the microbiological profile of the ulcer.  Over an 8 week period 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 2 
Date of First Enrollment (India)   26/12/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   Timolol has been used in very few studies for chronic ulcers; even those studies have used small sample sizes. Therefore, the therapeutic advantages of the medicine in chronic wounds need to be better supported by evidence. Hence, we proposed this study to determine whether topical timolol instillation, as opposed to standard wound treatment, will result in faster wound healing in chronic non-healing wounds.   
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