| CTRI Number |
CTRI/2024/02/063020 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess effectiveness and safety of topical insulin on wound healing |
|
Scientific Title of Study
|
An open–label,single-centric, parallel group,randomized controlled trial to assess effectiveness and safety of topical insulin in wound healing |
| 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 Meenu Thomas |
| Designation |
Assistant Professor Pharmacology |
| Affiliation |
Teerthanker Mahaveer University Medical College and Research Centre |
| Address |
C/O Department of Pharmacology
Teerthanker Mahaveer Medical College and Research Centre
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7626945238 |
| Fax |
|
| Email |
drmeenuthomas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Prithpal Singh Matreja |
| Designation |
Professor & Head Pharmacology |
| Affiliation |
Teerthanker Mahaveer University Medical College and Research Centre |
| Address |
C/O Department of Pharmacology
Teerthanker Mahaveer Medical College and Research Centre
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9855001874 |
| Fax |
|
| Email |
drpsmatreja@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenu Thomas |
| Designation |
Assistant Professor Pharmacology |
| Affiliation |
Teerthanker Mahaveer University Medical College and Research Centre |
| Address |
C/O Department of Pharmacology
Teerthanker Mahaveer Medical College and Research Centre
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7626945238 |
| Fax |
|
| Email |
drmeenuthomas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College and Research Centre, Moradabad, Uttar Pradesh, 244001. |
|
|
Primary Sponsor
|
| Name |
Dr Meenu Thomas |
| Address |
Department of Pharmacology, Teerthanker Mahaveer Medical College and Research Centre, Moradabad |
| 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 |
| DrMeenu Thomas |
Teerthanker Mahaveer Medical College and Research Centre, and Hospital Moradabad |
Department of General Surgery
Moradabad
UTTAR PRADESH |
7626945238
drmeenuthomas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMU Moradabad -Institutional Ethics Committee (TMU-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline |
1 ml normal saline (0.9%) for each 10 cm2 of wound, every 48 hours for 14 days |
| Intervention |
Regular Insulin also called Soluble Insulin |
4 units (0.1 ml) of human soluble insulin in 1 ml normal saline (0.9%) for each 10 cm2 of wound, every 48 hours for 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age18-65 years old
Either gender
Class I and II wound classifications as per CDC
Wound surface area (less than 20cm2)
Patients willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
Pregnancy
Patients on immunosuppressive treatment
Wounds that are complicated (e.g., Bleeding or infection)
Medications that may impact the study’s outcome
Cardiovascular illnesses, Peripheral artery disease or Renal and hepatic failure
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of topical insulin on wound healing |
Wound area in mm square shall be measured at day zero then at day 7 and then 14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study effectiveness & safety of topical insulin on wound healing |
For effectiveness
Wound depth in mm measured at day 7 & 14
The average time in which granulation tissue appears measured.
For safety
Random blood glucose 10 minutes before & after insulin application measured.
Spontaneously reported Adverse Drug Reactions (ADRs) noted as per ADR checklist at day zero then at day 7 & 14.
|
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/03/2024 |
| Date of Study Completion (India) |
07/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="3"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Topic: An open –label, single-centric, parallel group,
randomized controlled trial to assess effectiveness and safety of topical
insulin on wound healing
Aim: To assess effectiveness and safety of topical insulin
on wound healing.
Objectives:
To study the effectiveness of
topical insulin on wound healing.
To assess the safety of topical
Insulin
To compare the topical insulin
with normal saline in terms of efficacy and safety
STUDY DESIGN Open –label,
single-centric, parallel group, randomized controlled trial
STUDY LOCATION This study will be
done on patients visiting the OPD as well as the in-patients General Surgery of
Teerthanker Mahaveer Medical College and Research Centre, Moradabad.
STUDY PERIOD This study will be
conducted for ≃1.5 to 2 year after the approval from College Research Committee (CRC) and Institutional
Ethical Committee (IEC)
Sample size: 41 in each group, 82 total
Inclusion
criteria
Age18-65 years old
Either gender
Class 1 and 2 wound classifications as per CDC
Wound surface area 10 (less than 20cm2)
Patients willing to give informed consent
Exclusion
criteria
Pregnancy
Patients on immunosuppressive treatment
Wounds that are complicated (e.g., Bleeding or infection)
Medications that may impact the study’s outcome (NSAIDs etc.)
Cardiovascular illnesses, Peripheral artery disease or Renal and hepatic
failure
Treatment groups
Group A: insulin topical dressing
Group B: Normal saline topical dressing
Effectiveness assessment
Wound area, depth and pace and amount of granulation tissue. Pain
assessment measured at pre-determined time intervals
Safety Assessment
Blood glucose measurement and adverse drug reaction monitoring both spontaneous
and checklist |