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CTRI Number  CTRI/2026/02/104201 [Registered on: 18/02/2026] Trial Registered Prospectively
Last Modified On: 18/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Topical insulin therapy vs. Normal saline dressing in bedsore grade 2 and 3 
Scientific Title of Study   Topical insulin therapy vs. Normal saline dressing: A comparative study in the management of stage 2 and 3 bed sore wounds in a rural based tertiary health care centre. 
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 MANAS KUBAVAT 
Designation  JUNIOR RESIDENT 
Affiliation  DMMC NAGPUR 
Address  Department of general surgery,DATTA MEGHE MEDICAL COLLEGE NAGPUR

Nagpur
MAHARASHTRA
441110
India 
Phone  08980440402  
Fax    
Email  MANASKUBAVAT5@GMAIL.COM  
 
Details of Contact Person
Scientific Query  
Name  Vandana Sudhir Tomey 
Designation  JUNIOR RESIDENT 
Affiliation  DMMC NAGPUR 
Address  Department of general surgery, DATTA MEGHE MEDICAL COLLEGE NAGPUR
Near Vivekanand Kendra, Pratap Nagar , Nagpur.
Nagpur
MAHARASHTRA
441110
India 
Phone  08980440402  
Fax    
Email  MANASKUBAVAT5@GMAIL.COM  
 
Details of Contact Person
Public Query  
Name  DR MANAS KUBAVAT 
Designation  JUNIOR RESIDENT 
Affiliation  DMMC NAGPUR 
Address  Department of general surgery, DATTA MEGHE MEDICAL COLLEGE NAGPUR

Nagpur
MAHARASHTRA
441110
India 
Phone  08980440402  
Fax    
Email  MANASKUBAVAT5@GMAIL.COM  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DATTA MEGHE MEDICAL COLLEGE 
Address  DATTA MEGHE MEDICAL COLLEGE(DMMC), Datta Meghe Institute of Higher Education & Research (DMIHER), NAGPUR ,MAHARASHTRA ,441110 , INDIA 
Type of Sponsor  Private medical college 
 
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 MANAS KUBAVAT  SHALINITAI MEGHE HOSPITAL AND RESEARCH CENTRE  DEPARTMENT OF GENERAL SURGERY,DATTA MEGHE MEDICAL COLLEGE(DMMC), Datta Meghe Institute of Higher Education & Research (DMIHER), NAGPUR ,MAHARASHTRA ,441110 , INDIA
Nagpur
MAHARASHTRA 		 7227079074

MANASKUBAVAT5@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE,DATTA MEGHE MEDICAL COLLEGE,NAGPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L899||Pressure ulcer of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NORMAL SALINE DRESSING  NORMAL SALINE BED SORE DRESSING 
Intervention  TOPICAL INSULIN DRESSING  TOPICAL INSULIN DRESSING, HUMAN ACTRAPID INSULIN 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients aged 18 years and above
Presence of stage 2 or 3 pressure ulcers
Bedridden or immobilized patients
Willing to participate and provide written and informed consent 
 
ExclusionCriteria 
Details  Patients with stage 1 and stage 4 bed sores
Known hypersensitivity to insulin
Patients not consenting to participate  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
rate of wound healing increased   FOR 7 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   02/03/2026 
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)   Not Applicable 
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-identiļ¬cation.

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

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [MANASKUBAVAT5@GMAIL.COM].

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 17-02-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   my study is topical insulin therapy vs normal saline in bed sore grade 2 and 3  
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