| CTRI Number |
CTRI/2024/10/074708 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study the Effect of Local Insulin Injection in Patients with Diabetic Foot Ulcer. |
|
Scientific Title of Study
|
Effect of Local Insulin Injection on Wound Healing in Patients with Diabetic Foot Ulcer. |
| 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 Anupriya |
| Designation |
PG Resident |
| Affiliation |
Adesh Institute of Medical Sciences and Research |
| Address |
Department of general surgery ,unit 5 room number 2213
Adesh institute of medical and sciences
Bathinda
PUNJAB
151101
India |
| Phone |
7009925821 |
| Fax |
|
| Email |
sg6260748@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelesh Bansal |
| Designation |
Professor |
| Affiliation |
Adesh Institute of Medical Sciences and Rsearch |
| Address |
department of general surgery , unit 5 Adesh Institute of Medical Sciences and Rsearch Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9814975726 |
| Fax |
|
| Email |
neeleshbansal2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupriya |
| Designation |
PG Resident |
| Affiliation |
Adesh Institute of Medical Sciences and Rsearch |
| Address |
Department of general surgery ,unit 5 room number 2213
Adesh institute of medical and sciences
Bathinda
PUNJAB
151001
India |
| Phone |
7009925821 |
| Fax |
|
| Email |
sg6260748@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adesh Institute of Medical Sciences and Research , bathinda 151001 ,punjab , india |
|
|
Primary Sponsor
|
| Name |
Dr Anupriya |
| Address |
Adesh Institute of Medical Sciences and Research , bathinda 151001 ,punjab , india |
| Type of Sponsor |
Other [self] |
|
|
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 Anupriya |
Adesh Institute of Medical Sciences and Research |
department of general surgery ,unit 5, 2213.
Bathinda
PUNJAB |
7009925821
sg6260748@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Adesh University, Bathinda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, (2) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Insulin + Regular Dressing |
Wound of the patient will be cleaned with sterile normal saline (0.9% NaCl)then wound will be injected with human soluble insulin (regular)diluted in 1 ml saline for each 1cm2 of wound. The total dose of insulin will be the dose patient is already taking to control diabetes. The prepared solution will be injected clockwise on the ulcer base with an insulin syringe at 2,4,6,8,10,12 o clock position and then topically mupirocin cream will be applied then covered with sterile cotton gauze. only the morning dose of insulin will be injected into the wound.
dose- total dose will be the insulin which is already been prescribed to the patient for his/her diabetes control
frequency- will be once a day
route- subcutaneous in the wound base
duration- untill the wound heals (approx 20-30 days) |
| Comparator Agent |
Regular Dressing |
Wound of the patient will be cleaned with sterile normal saline (0.9% NaCl)and mupirocin ointment will be applied and covered with sterile cotton gauze. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who were diagnosed with diabetic foot ulcer.
2. Patients who are already on injectable insulin therapy subcutaneously with OHAs
3.voluntary participants with more than 18years who were able and willing to participate in the study
4.patients with relatively stable blood glucose levels, without the influence of diet, exercise, infection, stress or other factors that could affect systemic blood glucose
5.wounds without significant growth of granulation tissue.
6. Grade 2 and grade 3 ulcer according to European pressure ulcer classification.
|
|
| ExclusionCriteria |
| Details |
1. Patients with osteomyelitis, immunodeficient , varicose ulcer , patients with liver disease, kidney disease, skin malignancy and patients on chemotherapy or radiotherapy.
2. Patients with Hepatitis B , HCV or HIV positive.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Surface Area of the wound that is increasing or decreasing.
-Amount of Exudate from Wound and the type of Exudate whether it is foul smelling pus or serous fluid or serosanguinous discharge or Haemorrhagic.
-Granulation tissue whether it is healthy red , Pale Yellow ,White or Necrotic.
-Time duration required in healing of wound.
|
•Assessment of exudate, appearance of granulation, disappearance of slough , reduction in wound size will be seen on day 1,day 4 day 7 , day 14 and 21 between groups receiving insulin and saline dressing. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/10/2024 |
| Date of Study Completion (India) |
18/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is randomized parallel group single centre trial to study the effects of local insulin injection in wound healing in patients with diabetic foot ulcer that will be conducted in Adesh institue of medical sciences and research in india. The primary outcome measures will be the surface area of wound that is increasing or decreasing, amount of exudate from wound and type of exudate whether it is foul smelling pus or serous fluid or serosanguinous discharge or haemorrhagic, granulation tissue whether it is healthy red or pale yellow or white or necrotic, time duration required in healing of wound. |