| CTRI Number |
CTRI/2026/02/102910 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
14/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of topical insulin dressing versus normal saline dressing in diabetic foot ulcer. |
|
Scientific Title of Study
|
To Assess the effectiveness of topical insulin versus normal saline dressing in patients with diabetic foot ulcers: a prospective open labelled randomised controlled 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 Vimal Kumar Jain |
| Designation |
Consultant, Department of general surgery |
| Affiliation |
Mata Chanan Devi Hospital |
| Address |
Department of general surgery, Block C1, Janakpuri, New Delhi, Delhi
New Delhi
DELHI
110058
India |
| Phone |
9810027869 |
| Fax |
|
| Email |
dr.vimaljain1955@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vimal Kumar Jain |
| Designation |
Consultant, Department of general surgery |
| Affiliation |
Mata Chanan Devi Hospital |
| Address |
Department of general surgery, Block C1, Janakpuri, New Delhi, Delhi
New Delhi
DELHI
110058
India |
| Phone |
9810027869 |
| Fax |
|
| Email |
dr.vimaljain1955@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vimal Kumar Jain |
| Designation |
Consultant, Department of general surgery |
| Affiliation |
Mata Chanan Devi Hospital |
| Address |
Department of general surgery, Block C1, Janakpuri, New Delhi, Delhi
New Delhi
DELHI
110058
India |
| Phone |
9810027869 |
| Fax |
|
| Email |
dr.vimaljain1955@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mata Chanan Devi Hospital |
| Address |
Block C1, Janakpuri, New Delhi, Delhi |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nimish Jain |
Mata Chanan Devi Hospital |
Department of general surgery, Block-C1, Janakpuri, New Delhi
New Delhi
DELHI |
9057528277
nimishjain008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics CommitteeJanakpuri Super Specialty Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline Dressing |
1)Patients will be included in this study as per inclusion criteria on IPD basis.
2) Routine investigations (CBC, LFT, KFT, ECG, Chest X-Ray, HbA1C, Viral markers, USG Color Doppler) will be done.
3) Patients fulfilling the inclusion criteria will be divided into two groups.
4) In Group B normal saline will be used for dressing.
5) The solution will be then sprayed on the ulcer surface with an insulin syringe and the area will be left to dry and then covered with sterile cotton gauzes. Dressing will be done twice daily. In Group B, ulcers are cleaned with normal saline without insulin and covered with sterile gauzes.
6) All patients will be given Cap. Ampicillin 250 mg, Cloxacillin 250 mg qid at the time of admission. Metronidazole 400 mg tds will be given to all patients for anaerobic coverage. Later antibiotics will be changed according to pus culture and sensitivity reports.
7) Ulcer size, its depth, reduction in discharge and slough and granulation tissue will be evaluated. This evaluation will be done till a report of pus culture & sensitivity arrives.
8) Then patient will be discharged on appropriate medication and follow up will be done in subsequent OPD’s (Day 0,3,7,10,14)
9) Following parameters will be recorded subsequently
a) Mean Size (in cm2)
b) Mean Depth (in mm)
c) Is slough present or not
d) Is discharge present or not
e) Is granulation Healthy or not
f) Culture positivity
g) Need for grafting
h) Need for amputation
10) Statistical analysis will be carried out and data will be entered on excel sheet, and expressed as figures and tables with frequencies or number (N),and percentage (%). A p value of less than (0.05) will be considered significant. |
| Intervention |
Topical Insulin Dressing |
1) Patients will be included in this study as per inclusion criteria on IPD
basis.
2) Routine investigations (CBC, LFT, KFT, ECG, Chest X-Ray, HbA1C, Viral markers, USG Color Doppler) will be done.
3) Patients fulfilling the inclusion criteria will be divided into two groups.
4) In Group A, topical insulin will be used for dressing. In Group A, ulcers will be cleaned with
normal saline and then irrigated with 4 units (0.1 ml) of regular insulin (Human insulin Actrapid) in 1 ml normal saline (0.9%) for each 10 cm2 of wound. The cost of insulin will not be borne by the patient.
5) The solution will be then sprayed on the ulcer surface with an insulin syringe and the area will be left to dry and then covered with sterile
cotton gauzes. Dressing will be done twice daily. In Group B, ulcers are cleaned with normal saline without insulin and covered with sterile gauzes.
6) All patients will be given Cap. Ampicillin 250 mg, Cloxacillin 250 mg qid at the time of admission. Metronidazole 400 mg tds will be given to
all patients for anaerobic coverage. Later antibiotics will be changed according to pus culture and sensitivity reports.
7) Ulcer size, its depth, reduction in discharge and slough and granulation tissue will be evaluated. This evaluation will be done till a report of pus culture & sensitivity arrives.
8) Then patient will be discharged on appropriate medication and follow up will be done in subsequent OPD’s (Day 0,3,7,10,14)
9) Following parameters will be recorded subsequently
a) Mean Size (in cm2)
b) Mean Depth (in mm)
c) Is slough present or not
d) Is discharge present or not
e) Is granulation Healthy or not
f) Culture positivity
g) Need for grafting
h) Need for amputation
10) Statistical analysis will be carried out and data will be entered on excel sheet, and expressed as figures and tables with frequencies or number (N),and percentage (%). A p value of less than (0.05) will be considered significant. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 30 years in both sexes presenting with any grade of diabetic foot ulcer and not included in any other study. |
|
| ExclusionCriteria |
| Details |
Patient with severe malnutrition.
Patient with HbA1c more than 9% .
Patients having peripheral vascular disease with flow limitation.
Patients with immunocompromised diseases or taking immunosuppressants (eg.
steroid).
X-ray showing features of osteomyelitis.
Patients with ulcers other than diabetic ulcers.
Patients with gangrene. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To examine the effectiveness of topical insulin over conventional methods in patients with Diabetic Foot Ulcers and compare the outcome in terms of reduction in wound size |
Patient will be discharged on appropriate medication and follow up will be done in subsequent OPD’s (Day 0,3,7,10,14)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the outcome in terms of duration of hospital stay. |
patient will be discharged on appropriate medication & follow up will be done in subsequent OPD’s (Day 0,3,7,10,14)
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
13/02/2026 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Chronic wounds are those that fail to heal within three months despite optimal management and are commonly seen in conditions such as diabetic foot ulcers and pressure sores. They affect millions worldwide, with a significant burden in India. Diabetic foot ulcers are particularly common in older patients and are associated with poor healing, high risk of infection, osteomyelitis, gangrene, and possible amputation. Insulin has properties that reduce inflammation, enhance collagen deposition, promote protein synthesis, and support re epithelialisation. Topical insulin has therefore emerged as a potential therapy for non healing diabetic ulcers.
This study is a prospective open labelled randomized controlled trial conducted over eighteen months in the Department of General Surgery at Mata Chanan Devi Hospital, New Delhi. It aims to evaluate the effectiveness of topical insulin dressing compared to normal saline dressing in patients with diabetic foot ulcers. The primary objective is to compare wound healing based on reduction in wound size, and the secondary objective is to compare duration of hospital stay.
A total of fifty patients will be included, with twenty five patients in each group, randomized in a one to one ratio. Group A will receive topical insulin dressing, while Group B will receive conventional normal saline dressing. Wound parameters such as size, depth, presence of slough or discharge, granulation tissue, culture results, need for grafting, need for amputation, and hospital stay will be assessed at regular intervals. Statistical analysis will be performed using appropriate tests to compare outcomes between groups. Ethical approval and informed consent will be obtained prior to the study. |