| 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
|
|
|
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
|
|
|
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. |