| CTRI Number |
CTRI/2025/04/084649 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of a novel antiseptic solution -"Nanoparticle enabled mathan thailam" dressing versus Platelet rich plasma dressing versus hydrogel dressing for diabetic foot patients. |
|
Scientific Title of Study
|
Developing a nanoparticle enabled solution with mathan thailam for patients with
diabetic foot ulcer showing better healing PRP and hydrogel |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthikeyan S |
| Designation |
Postgraduate, General Surgery |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Department of General Surgery, Room no.201,
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9597410933 |
| Fax |
|
| Email |
karthikeyans998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.P.B.Sudarshan |
| Designation |
Professor, HOD research |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Department of General Surgery,
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
978959925 |
| Fax |
|
| Email |
pbsudarshan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Karthikeyan S |
| Designation |
Postgraduate, General Surgery |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Department of General Surgery, Room no.201,
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9597410933 |
| Fax |
|
| Email |
karthikeyans998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105, India |
|
|
Primary Sponsor
|
| Name |
Dr.Karthikeyan.S |
| Address |
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai -602105 |
| Type of Sponsor |
Other [By 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 |
| DrKarthikeyanS |
Saveetha Medical College and Hospital |
Department of General Surgery, Room no.201,
Saveetha Nagar, Thandalam,
Chennai - 602105, Tamil Nadu, India
Chennai
TAMIL NADU |
9597410933
karthikeyans998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E13||Other specified diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BioZn MT |
Topical application of the solution covering the total surface of the ulcer is given daily for 14 days |
| Comparator Agent |
Hydrogel |
Topical application of the solution covering the total surface of the ulcer is given daily for 14 days |
| Comparator Agent |
Platelet rich plasma |
Topical application of the solution covering the total surface of the ulcer is given daily for 14 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with diabetes mellitus presenting foot ulcer |
|
| ExclusionCriteria |
| Details |
Patients without diabetes mellitus presenting foot ulcer |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time of appearance of red granulation tissue |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete closure of the wound |
1 month |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
13/04/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a randomized, double blinded, parallel group, single centre trial comparing the efficacy of topical therapy of mathan thailam with zinc oxide nanoparticle for 1 month with PRP and hydrogel for 1 month in patients with diabetic foot ulcer. A total of 42 patients are to be included in the trial. The primary outcome is better healing in patients using mathan thailam enabled with zinc oxide. |