| CTRI Number |
CTRI/2025/01/079002 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare efficacy of topical insulin, topical phenytoin and standard wound care for treatment of trophic ulcers in patients with leprosy |
|
Scientific Title of Study
|
Comparative efficacy of topical insulin, topical phenytoin and standard wound care for treatment of trophic ulcers in patients with leprosy: A Hospital Based Randomized Controlled 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 |
Dr Kaushiki Suman |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Dermatology & Venerology, AIIMS Gorakhpur, Kunraghat
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9968381580 |
| Fax |
|
| Email |
kaushikisuman1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Kumar Gupta |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Dermatology & Venerology, AIIMS Gorakhpur, Kunraghat
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9838844937 |
| Fax |
|
| Email |
dr.sunil_30@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Kumar Gupta |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Dermatology & Venerology, AIIMS Gorakhpur, Kunraghat
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9838844937 |
| Fax |
|
| Email |
dr.sunil_30@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Gorakhpur, Uttar Pradesh, India, Pincode:273008 |
|
|
Primary Sponsor
|
| Name |
Dr. Kaushiki Suman |
| Address |
Department of Dermatology and Venereology, AIIMS Gorakhpur, UP-273008 |
| 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 Kaushiki Suman |
All India Institute of Medical Sciences, Gorakhpur |
Room no.226, Department of Dermatology and Venereology
Gorakhpur
UTTAR PRADESH |
9968381580
kaushikisuman1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L984||Non-pressure chronic ulcer of skin, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Wound Care of trophic ulcer |
Standard wound care includes debridement of ulcer, if necessary, then cleaning of the ulcer with Povidone Iodine solution and Normal Saline solution and then application of Mupirocin ointment then dressing with sterile cotton gauze pad for treatment of trophic ulcer in patients of leprosy. This will be done once daily and for a maximum of 8 weeks or till the ulcer heals completely whichever is earlier. |
| Intervention |
Topical Insulin on trophic ulcer |
Application of topical Insulin solution over ulcer along with standard wound care will be done in patients of leprosy as mentioned in the comparator group. This will be done once daily and for a maximum of 8 weeks or till the ulcer heals completely whichever is earlier. |
| Intervention |
Topical Phenytoin on trophic ulcer |
Application of topical Phenytoin paste over ulcer along with standard wound care will be done in patients of leprosy as mentioned in the comparator group. This will be done once daily and for a maximum of 8 weeks or till the ulcer heals completely whichever is earlier. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between the age group of 18 to 75 years.
2. Wound area size less than 50 square centimeters.
3. Patients with well controlled diabetes. |
|
| ExclusionCriteria |
| Details |
1. Patients not consenting to the study.
2. Patients with malignant ulcers.
3. Patients with gross cellulitis.
4. Patient with underlying osteomyelitis.
5. Patients with lepra reactions.
6. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical response as indicated by percentage of ulcer area reduction between the three treatment groups after 8 weeks. |
From baseline to the end of follow up at 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical response as indicated by percentage of ulcers achieving complete healing at the end of 8 weeks in each treatment group. |
From baseline to the end of follow up at 8 weeks. |
| Clinical response as indicated by rate of healing of ulcer in each treatment group. |
From baseline to the end of follow up at 8 weeks. |
| Assessing the Dermatology Life Quality Index (DLQI) before, during and after completion of 8 weeks. |
From baseline to the end of follow up at 8 weeks. |
| Assessing the Physician Global Assessment Score (PGA) before and after completion of 8 weeks. |
From baseline to the end of follow up at 8 weeks. |
| Assessing the Incidence of various side effects with Topical Insulin therapy, Topical Phenytoin therapy and Standard Wound Care therapy. |
From baseline to the end of follow up at 8 weeks. |
| Assessing the Strength of Association of identified risk factors to wound healing. |
From baseline to the end of follow up at 8 weeks. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2025 |
| 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="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 compare the efficacy of topical insulin, topical phenytoin and standard wound care for the treatment of trophic ulcers in patients with leprosy over a 8 week period of follow up. |