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CTRI Number  CTRI/2025/07/090902 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On: 30/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Insulin dressing for diabetic foot ulcer 
Scientific Title of Study   Effectiveness of topical Insulin in Diabetic Foot Ulcer compared to normal saline dressing among inpatients of a tertiary health centre: 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  Porshiya  
Designation  Post graduate  
Affiliation  Indira Gandhi medical College and research institute  
Address  Indira Gandhi medical College and research institute vazhudavur road kadhirkamam puducherry

Pondicherry
PONDICHERRY
605009
India 
Phone  8220799915  
Fax    
Email  porshfredy0708@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Simon David dasiah 
Designation  Head of the department  
Affiliation  Indira Gandhi medical College and research institute  
Address  Department of general surgery Indira Gandhi medical College and research institute vazhudavur road kadhirkamam puducherry

Pondicherry
PONDICHERRY
605009
India 
Phone  9443209182  
Fax    
Email  sdasiah@msn.com  
 
Details of Contact Person
Public Query
 
Name  Simon David dasiah  
Designation  Head of the department  
Affiliation  Indira Gandhi medical College and research institute  
Address  Department of general surgery indira Gandhi medical College and research institute kadhirkamam

Pondicherry
PONDICHERRY
605005
India 
Phone  9443209182  
Fax    
Email  sdasiah@msn.com  
 
Source of Monetary or Material Support  
Indira Gandhi medical College and research institute Vazhudavur road Kadhirkamam Puducherry 605009 
 
Primary Sponsor  
Name  Indira Gandhi medical College and research institute  
Address  Vazhudavur road kadhirkamam puducherry 605009 
Type of Sponsor  Research institution 
 
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 porshiya  indira gandhi medical college and research institute  department of general surgery
Pondicherry
PONDICHERRY 
8220799915

porshfredy0708@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
indira gandhi medical college and research institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E138||Other specified diabetes mellituswith unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  insulin dressing- daily once . observation(assessement of the ulcer) will be made every two days for 2 weeks duration   Participants will receive topical insulin dressing, including regular anti diabetic medications.(4 units of 0.1ml mixtard with 1ml normal saline for 10cm sq of wound ) 
Comparator Agent  normal saline dressing daily once . observation(assessement of the ulcer) will be made every two days for 2 weeks duration   Participants will receive Normal saline dressing(1ml normal saline for 10cm sq of wound), mirroring the topical insulin along with their regular anti diabetic medications.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  a. Adult individuals (age 18 and above) diagnosed with diabetes(Type 1 and 2). b. Presence of diabetic foot ulcers confirmed through clinical evaluation. c. Willingness to participate and provide informed consent.
d. Grade 1 and 2 of diabetic ulcer (Wagner-Meggitt classification). 
 
ExclusionCriteria 
Details  a. Patients with previous surgery for diabetic foot earlier b. Allergic reactions or contraindications to insulin. c. Non-compliance with the treatment plan d. X-ray features of osteomyelitis
e. Doppler showing gross atherosclerotic changes and venous abnormalities
f. Other clinically significant medical conditions that would impair wound healing (renal, hepatic, immunodeficiency, hematological, neurological diseases and malignancies)
g. patients in intensive care unit.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
parameters : based on bates jenson score
size of the ulcer
depth
edge
necrotic tissue
exudate
undermining of edges
peripheral tissue edema , induration
granulation tissue
epithelialization . 
day 2, day 4, day 6, day 8, day 10, day 12 , day 14. 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in rate of healing between saline & insulin   At 2nd 4th 6th 8th 10th 12th 14th day  
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   01/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/01/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  

 all the consented participants will be admitted and would undergo the following investigations. Complete blood count, Fasting, postprandial blood sugar ,LFT , RFT , HbA1C , Doppler, X-ray , wound swab / pus culture sensitivity. Initial wound debridement (if needed) - removal of necrotic debris, slough, foreign body will be done. Patients will be selected by consecutive sampling , randomized into two groups by block randomization and allocation concealment will be done by SNOSE technique.Initial wound assessment will be done before randomization by the principle investigator. Both the groups will be started on empirical intravenous antibiotics (cefotaxime and metronidazole) which will be modified after the culture sensitivity reports, will receive same Diabetic diet from hospital, and their diabetic medications (such that blood glucose values are controlled).No intervention will be done for the systemic disease of the patient. Patients will be receiving daily dressing : test group will be receiving insulin dressing and the control group will be receiving normal saline dressing . The dressing solutions will be freshly prepared and opaque containers will be used. Periodical wound assessment will be done during the hospital stay using bates jenson wound assessment tool. Once the wound is healed or after two weeks (whichever is earlier) , the patient will be discharged.

 

 
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