| CTRI Number |
CTRI/2024/08/072695 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To check how insulin treatment helps in healing wounds in Leprosy patients |
|
Scientific Title of Study
|
A Prospective study to evaluate the efficacy of insulin therapy in the treatment of chronic nonhealing and trophic ulcers in Hansen’s Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanth G |
| Designation |
Postgraduate Resident |
| Affiliation |
Govt Stanley Medical College |
| Address |
Department of Dermatology, Venereology and Leprology, Govt Stanley Medical College No.De01,Old jail road, George Town, Chennai-01
Chennai
TAMIL NADU
600001
India |
| Phone |
9597166530 |
| Fax |
|
| Email |
drprasanthprakasam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sowmiya R |
| Designation |
Associate Professor |
| Affiliation |
Govt Stanley Medical College |
| Address |
Department of Dermatology,Venereology and Leprology,
Govt Stanley Medical College No.De01,Old jail road, George Town, Chennai-01
Chennai
TAMIL NADU
600001
India |
| Phone |
9842403621 |
| Fax |
|
| Email |
drrsowmiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prasanth G |
| Designation |
Postgraduate Resident |
| Affiliation |
Govt Stanley Medical College |
| Address |
Department of Dermatology,Venereology and Leprology
Govt Stanley Medical College No.De01,Old jail road, George Town, Chennai-01
Chennai
TAMIL NADU
600001
India |
| Phone |
9597166530 |
| Fax |
|
| Email |
drprasanthprakasam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Stanley Medical College and Hospital, No.01, Old jailroad, GeorgeTown,
Chennai-600001 Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Prasanth G |
| Address |
Department of Dermatology,Venereology and Leprology,Government Stanley Medical College and Hospital,
No.01, Old jail road, George Town, Chennai-01 |
| 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 Prasanth G |
Government Stanley Medical College and Hospital |
Department of DVL NO,32 Leprosy OP, near casualty building
Chennai
TAMIL NADU |
9597166530
drprasanthprakasam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Govt Stanley Medical College & Hospital, Chennai-01 Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L899||Pressure ulcer of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Insulin Therapy |
After cleaning the ulcer wound with normal saline, insulin 0.1 ml with 0.9 ml NS diluted and applied over the ulcer bed and dressing done every alternate days till 12 weeks |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Trophic ulcers of more than 6 weeks duration
Trophic ulcers of size less than 10x10 cm
Ulcers pus culture sensitivity showing no growth |
|
| ExclusionCriteria |
| Details |
Age more than 75 and less than 18 years
Trophic ulcers of size more than 10x10 cm
Infected Ulcers
Uncontrolled diabetes and Hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing of Trophic ulcer |
Every week upto 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patients mobilisation |
After 3 months |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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)
|
Not Applicable |
| 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
|
To evaluate the efficacy of insulin therapy in chronic nonhealing and trophic ulcers in Hansen’s patients Insulin (0.1 ml short acting insulin) diluted in 0.9 ml Normal saline sprayed over the ulcer bed and occlusion dressing done every alternate days till healing of ulcers or 12 weeks whichever is earlier |