| CTRI Number |
CTRI/2025/08/093948 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Compare the effect of Local insulin Injection and conventional normal Saline dressing on healing of diabetic foot ulcer. |
|
Scientific Title of Study
|
The Efficacy of Local Insulin Injection Vs Conventional Normal Saline Dressing in Diabetic Foot Ulcer Management: A Randomized Control Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRASSANNA RAJU |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCEINCES |
| Address |
WARD 8
DEPARTMENT OF GENERAL SURGERY GANAPATHICHETTIKULLAM,KALAPET, PUDUCHERRY - 605014
ROOM NUMBER 125
ANNEXE/ PG HOSTEL
GANAPATHICHETTIKULLAM,KALAPET, PUDUCHERRY - 605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9600379487 |
| Fax |
91-413-2656273 |
| Email |
prasanathiruvarasan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. ASHWIN CHAND |
| Designation |
PROFESSOR |
| Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCEINCES |
| Address |
WARD 8, DEPARTMENT OF GENERAL SURGERY (OFFICE)
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES,
GANAPATHICHETTIKULLAM,KALAPET, PUDUCHERRY - 605014.
WARD 8, DEPARTMENT OF GENERAL SURGERY (OFFICE)
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES,
GANAPATHICHETTIKULLAM,KALAPET, PUDUCHERRY - 605014.
Pondicherry
PONDICHERRY
605014
India |
| Phone |
8489006986 |
| Fax |
91-413-2656273 |
| Email |
ashwin.chand84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRASSANNA RAJU |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCEINCES |
| Address |
WARD 8, DEPARTMENT OF GENERAL SURGERY,
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES,
GANAPATHICHETTIKULLAM,KALAPET, PUDUCHERRY - 605014
ROOM NUMBER 125, PG HOSTEL
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES,
GANAPATHICHETTIKULLAM,KALAPET, PUDUCHERRY - 605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9600379487 |
| Fax |
91-413-2656273 |
| Email |
prasanathiruvarasan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PRASSANNA RAJU |
| Address |
GANAPATHICHETTIKULAM, KALAPET, PUDUCHERRY - 605014 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DRPRASSANNA RAJU |
PONDICHERRY INSTITUE OF MEDICAL SCIENCES |
WARD 8, DEPARTMENT OF GENERAL SURGERY,
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES, GANAPATHICHETTIKULAM, KALAPET, PUDUCHERRY - 605014
Pondicherry
PONDICHERRY |
9600379487
91-413-2656273
prasanathiruvarasan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMMITEE |
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 |
| Intervention |
INSULIN |
HUMAN ACTRAPID, from the total dose of short acting insulin (Human Actrapid) required for the patient (per day) half of it is diluted with 1 ml sterile water and injected into the base of the wound with 1 ml syringe, and the remaining half of the requirement is injected subcutaneously in the anterior abdominal wall, daily for 10 days. |
| Comparator Agent |
NORMAL SALINE |
0.9% SODIUM CHLORIDE
In Diabetic foot ulcer patients, full calculated dose of insulin will be given subcutaneously in the anterior abdominal wall and wound dressing will be done using normal saline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Diabetic foot ulcer with Grade 2 of Wagner Meggit classification
2) Age More than 18 years
|
|
| ExclusionCriteria |
| Details |
1) Patient in sepsis
2) Immunocompromised patient - HIV, HBsAg, HCV, and another disease that requires steroids as treatment.
3) Patient with renal failure
4) Patient with Severe Anemia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The percentage reduction of wound size in Group A is 79.7 % and the Percentage reduction in Group B is 40.84 % |
The rate of regression of wound size, slough reduction, and presence of granulation tissue will be measured in day one and 7th, 14th and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the factors associated with wound healing among the patients with diabetic foot ulcer. |
The rate of regression of wound size, slough reduction, & presence of granulation tissue will be measured in day one & 7th, 14th & 21st day |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| 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="0"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Title
of the dissertation, The Efficacy of Local Insulin Injection vs Conventional
Normal Saline Dressing in Diabetic Foot Ulcer Management: A Randomized Controlled
Study. In
this study, we are using local insulin and comparing it with normal saline
dressing in diabetic foot ulcers, to find out which of the above dressing enhances
wound healing. Objectives are To Compare the effect of Local insulin Injection and
conventional normal Saline dressing on healing of diabetic foot ulcer and To identify the factors associated with wound healing
among the patients with diabetic foot ulcer. Study
settings Tertiary care hospital, in Pondicherry, 740 bedded hospital, NABH, NABL, NAAC
Accredited. Sample size is 64, 32 in each arm. After applying inclusion and exclusion criteria and after getting consent, Group A, from
the total dose of short acting insulin (Human Actrapid) required for the
patient (per day) half of it is diluted with 1 ml sterile water and injected
into the base of the wound with 1 ml syringe, and the remaining half of the
requirement is injected subcutaneously in the anterior abdominal wall, daily
for 10 days. Group
B, full calculated dose of insulin will be given subcutaneously in the anterior
abdominal wall and wound dressing will be done using normal saline. Ulcer evaluation will be done by measuring ulcer
area using a Transparent graph sheet, slough area is marked separately Wound healing is observed by measuring the ulcer
size, depth, and presence of granulation tissue every week for 3 week. Analysis
is done by comparing the rate of regression of wound size between the two
groups.
Wound
healing and slough reduction is compared between the two groups The rate of regression of wound size, slough
reduction, and presence of granulation tissue will be measured in day one and 7th,
14th and 21st day.
|