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CTRI Number  CTRI/2021/05/033671 [Registered on: 18/05/2021] Trial Registered Prospectively
Last Modified On: 19/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of local application of insulin on diabetic wound healing 
Scientific Title of Study   Effect of topical insulin on diabetic wound healing 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Surya Yashaswi PVS 
Designation  Junior Resident 
Affiliation  Kasturba Medical College 
Address  2nd floor, Dept. of General Surgery, Shri Madhav Pai OPD Building, Kasturba Hospital, Madhav Nagar, Manipal, Udupi District
Kasturba Medical College, Madhav Nagar, Manipal, Udupi District
Udupi
KARNATAKA
576104
India 
Phone  9949663399  
Fax    
Email  peddireddi.yashaswi@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Annappa Kudva 
Designation  Professor and HOU 
Affiliation  Kasturba Medical College 
Address  2nd floor, Dept. of General Surgery, Shri Madhav Pai OPD Building, Kasturba Hospital, Madhav Nagar, Manipal, Udupi District
Kasturba Medical College, Madhav Nagar, Manipal, Udupi District
Udupi
KARNATAKA
576104
India 
Phone  9448857394  
Fax    
Email  annappa.kudva@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Bharath SV 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College 
Address  2nd floor, Dept. of General Surgery, Shri Madhav Pai OPD Building, Kasturba Hospital, Madhav Nagar, Manipal, Udupi District
Kasturba Medical College, Madhav Nagar, Manipal, Udupi District
Udupi
KARNATAKA
576104
India 
Phone  9148586336  
Fax    
Email  bharath.sv@manipal.edu  
 
Source of Monetary or Material Support  
Post Graduate Thesis Research Grant: Kasturba Medical College, Manipal. 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Kasturba Medical College, Madhav Nagar, Manipal, Udupi District, Karnataka 576104 
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 
Surya Yashaswi PVS  Department of General Surgery, Kasturba Medical College and Hospital  2nd floor, Shri Sharda Madhav Pai OPD, Department of General Surgery, MAHE, Madhav nagar, Manipal
Udupi
KARNATAKA 		 9949663399

peddireddi.yashaswi@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E108||Type 1 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal Saline  This group will receive dressing with normal saline. This is a standard of care for treating a diabetic ulcer.The wound will be dressed and assessed on day0, day 3, day 6, day 9, day 12 and day 15. 
Intervention  Topical Insulin (H. Actrapid)  This group will receive dressing with insulin using 0.4units per cm2 of the wound. The solution will be sprayed over the surface of ulcer with a syringe. The wound will be dressed and assessed on day0, day 3, day 6, day 9, day 12 and day 15. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  • Patients with diabetic ulcers (both type 1 & type 2) in lower limbs.
• Patients who are above 18 years of age
• Patients with ulcer area of ≤ 30cm2.
• Patients with Grade 0, 1 and Stage A, C according to University of Texas Diabetic Wound classification.
• Patients who are willing to participate in study voluntarily.
 
 
ExclusionCriteria 
Details  • Patients with Grade 2, 3 and Stage B, D according to University of Texas Diabetic wound classification.
• Patients with peripheral vascular disease as in those who have monophasic flow in ultrasound
doppler.
• Burns wounds and Pressure sores
• Patients with venous ulcers.
• Patients more than 70 years old.
• Patients on systemic steroid therapy or immune-compromised patients.
• Non compliant patients.
• Patients with GRBS <100 mg/dl before the dressing.( Safety check)
• Pregnant female patients
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Topical insulin dressings over the routine saline dressings by comparing percentage reduction in the surface area of the ulcer.  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Topical insulin application on reducing the wound healing time by comparing the time taken for the ulcer to decrease in size.  15 days 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   25/05/2021 
Date of Study Completion (India) 04/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 04/10/2022 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Patients with diabetic foot ulcers who present to the outpatient department are considered for the study. Once patients willing for the study, randomisation will be done by using coloured envelope method. Blue envelope for Group A(Intervention group), pink envelope for Group B(control group).

The ulcers are first washed with saline. The ulcer will be then examined and based on inclusion and exclusion criteria, they will be taken into study either on admission basis or on Outpatient Department basis , depending upon the patient.

Appropriate history will be taken and measurements of ulcer will be documented using a paper ruler. The wound size will be calculated by taking the longest diameter (a) in cm, and multiplying with its perpendicular diameter (b) so that, area of the wound is obtained in cm2.

Based on their randomisation group patients will receive dressing.

Group A will receive dressing with insulin using 0.4units per cm2 of the wound. The solution will be sprayed over the surface of ulcer with a syringe.

Group B will receive dressing with normal saline. This is a standard of care for treating a diabetic ulcer.

 

The wound will be dressed and assessed on day0, day 3, day 6, day 9, day 12 and day 15  in both the groups.

 This study will not affect patient’s systemic antibiotic therapy.

Care will be taken that these admissions are for periodic dressings and not for other health reasons. It will be made clear to the patients that their stay is not merely for the sake of study. The concerned patient’s physician is informed about the additional insulin doses and RBS levels in case there is a fluctuation during the course of study in order to adjust regular insulin accordingly.

The study does not involve blinding of participants and investigator. GRBS will be done half an hour prior to the dressing as a part of treatment protocol. This GRBS test will be done using the procured glucometer and strips.

 
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