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CTRI Number  CTRI/2024/03/064005 [Registered on: 12/03/2024] Trial Registered Prospectively
Last Modified On: 12/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial to estimate role of topical vitamin A on chronic wounds. 
Scientific Title of Study   Randomized control trial of short-contact topical vitamin A ointment on chronic non-healing wounds compared to standard dressings in a tertiary care center.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monisha.S 
Designation  MBBS, JR MS General surgery 
Affiliation  Akash institute of medical sciences and research center 
Address  #19, 3rd floor, above Ravi eye clinic, opposite to Shoba windfall apartments, Jakkur main road, Amruthahalli, Bangalore-560092
Department of general surgery, Akash institute of medical sciences and research center, Prasannahalli main road, Devanahalli, Bangalore, Karnataka-562110
Bangalore
KARNATAKA
560092
India 
Phone  9686234160  
Fax    
Email  monisha2710sampath@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR. Venkatkrishna.B.R 
Designation  MBBS, MS GENERAL SURGERY 
Affiliation  Akash institute of medical sciences and research center 
Address  Department of general surgery, Akash institute of medical sciences and research center, Prasannahalli main road, Devanahali, Banaglore.
Department of general surgery, Akash institute of medical sciences and research center, Prasannahalli main road, Devanahali, Banaglore, 562110
Bangalore
KARNATAKA
562110
India 
Phone    
Fax    
Email  venkatkrishnabr@gmail.com  
 
Details of Contact Person
Public Query  
Name  MONISHA S 
Designation  MBBS, JR MS GENERAL SURGERY 
Affiliation  Akash institute of medical sciences and research center 
Address  Department of general surgery, Akash institute of medical sciences and research center, Prasannahalli main road, Devanahali, Banaglore.
Department of general surgery, Akash institute of medical sciences and research center, Prasannahalli main road, Devanahali, Banaglore.
Bangalore
KARNATAKA
562110
India 
Phone  9686234160  
Fax    
Email  monisha2710sampath@gmail.com  
 
Source of Monetary or Material Support  
Infrastructure Support- Department of general surgery, Akash institute of medical college and research center 
 
Primary Sponsor  
Name  DRMonishaS 
Address  #19, 3rd floor, above Ravi eye clinic, opposite to Shobha windfall apartments, Jakkur main road, Amruthahalli, Bangalore-562110. 
Type of Sponsor  Other [Principal investigator] 
 
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 
DRMonishaS  Akash institute of medical sciences and research center  Department of general surgery, Akash institute of medical sciences and research center, Prasannahalli main road, Devanahali, Banaglore, 562110
Bangalore Rural
KARNATAKA 		 9686234160

monisha2710sampath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Akash medical college and research center, Institutional ethhics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  BETADINE SOLUTION  in control group, the wounds are wash with betadine solution, irrigated with normal saline and packed with gauze dressings. It is done daily for initial 1 week, followed by alternate days for next 3 weeks.  
Intervention  VITAMIN A OINTMENT (0.05% TRETINOIC ACID)  Less than one finger-tip unit of 0.05% (tretinoin)vitamin A ointment will be applied topically over the wounds, left for 10 minutes and thoroughly irrigated with normal saline. Then the wound is packed with gauze dressings. The process is repeated daily for 1 week, followed by alternate days for the next 3 weeks. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Giving written informed consent
2.Patients with chronic non-healing ulcer
3.Size of ulcer more than 0.5x0.5 cm but less than 10x10 cm
4.Duration of wound more than 3 weeks.
 
 
ExclusionCriteria 
Details  1.Age less than 19 years
2.Large wounds more than 11x11cm
3.Infective ulcers
4.Chronic liver disease
5.Chronic renal disease
6.Deranged lipid profile
• Taking vitamin A supplements
• Severe protein malnutrition
• Pregnant and lactating women
• Loss to follow-up
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical improvement of ulcer as assessed by push tool 3.0.  Weekly assessment for 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Decreased ulcer area & depth in study group when compared to control group.  Weekly assessment for 4 weeks. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/03/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [monisha2710sampath@gmail.com].

  6. For how long will this data be available start date provided 05-01-2026 and end date provided 05-12-2085?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

  1. Need for Study:Chronic wounds pose significant challenges due to prolonged healing times, affecting patients’ quality of life and incurring substantial healthcare costs. Available treatments often have limited success, necessitating advanced wound care therapies. Vitamin A has shown promise in wound healing, but its direct application to wounds requires further investigation.

  2. This study aims to investigate the efficacy of topical vitamin A ointment on chronic non-healing wounds compared to standard dressings.

  3. Literature Review: Previous studies have indicated the potential benefits of topical vitamin A in promoting wound healing. Experimental studies in animals and observational trials in humans have demonstrated accelerated healing and increased granulation tissue formation with topical retinoids.

  4. Study Objectives:

    • To observe the effect of topical vitamin A ointment on chronic non-healing wounds using the Pressure Ulcer Scale for Healing (PUSH) tool.
    • To compare the changes in ulcer dimensions after daily dressings with topical vitamin A ointment versus standard dressings over a four-week period.

  5. Materials and Methods:

    • Study Design: Randomized Controlled Trial
    • Study Period: March 2024 to September 2025
    • Sample Size: 50 patients with chronic non-healing ulcers
    • Inclusion and Exclusion Criteria specified
    • Stratified Random Sampling method used for patient selection

  6. Methodology:

    • Single-blind RCT with patients randomized into two groups: one receiving topical vitamin A ointment and the other standard dressings.
    • Dressing protocol involves daily application of vitamin A ointment followed by alternate day dressings for four weeks.
    • Ulcer measurements and assessment conducted weekly.
    • Conclusion:
    • The study aims to provide evidence for the effectiveness of topical vitamin A ointment in promoting the healing of chronic non-healing wounds, potentially offering a cost-effective and beneficial treatment option
 
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