| CTRI Number |
CTRI/2025/02/080865 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Development and Evaluation of a Novel Topical Gel Formulation Comprising Colloidal Silver Nanoparticles, Aloe Vera Gel, and Chitosan for Ulcer Treatment in diabetic patients |
|
Scientific Title of Study
|
A new topical gel using combination of Colloid Silver Nanoparticles, Aloe Gel and Chitosan for treatment of ucler in diabetic 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 |
Dr Aravind K |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of General Surgery, Saveetha Medical college and Hospital, Saveetha Nagar, thandalam, chennai bengaluru NH48
Chennai
TAMIL NADU
602105
India |
| Phone |
9176145384 |
| Fax |
|
| Email |
aravindak95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Rajeshkumar |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Nanobiomedicine, Saveetha Medical college and Hospital, Saveetha Nagar, thandalam, chennai bengaluru NH48
Chennai
TAMIL NADU
602105
India |
| Phone |
9629739263 |
| Fax |
|
| Email |
rajeshkumars.smc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Rajeshkumar |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Nanobiomedicine, Saveetha Medical college and Hospital, Saveetha Nagar, thandalam, chennai bengaluru NH48
Chennai
TAMIL NADU
602105
India |
| Phone |
9629739263 |
| Fax |
|
| Email |
rajeshkumars.smc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, thandalam, Chennai- 602105 |
|
|
Primary Sponsor
|
| Name |
Dr. Aravind. K |
| Address |
Saveetha Medical college and hospital
Saveetha Nagar, Thandalam, Chennai bengaluru NH48, chennai- 602015 |
| 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 Aravind K |
Saveetha Medical College and Hospital |
Department of General Surgery,Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai- 602105
Kancheepuram
TAMIL NADU |
9176145384
aravindak95@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: L979||Non-pressure chronic ulcer of unspecified part of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amorphous hydrogel with colloid silver |
Colloid silver 32PPM
Gel base- Quantity sufficient for 3 months |
| Intervention |
colloidal silver nanoparticles, aloe gel, and chitosan |
25GM OF CMC gel and 25GM of carbopol gel and 5ml of AgNCs + Aloe vera gel solution added to it for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with Diabetic foot ulcers with devitalised tissue which are amenable to heal without any amputation
2. Subjects with Type II Diabetes mellitus
3. Subjects without any other contributory comorbidities.
|
|
| ExclusionCriteria |
| Details |
1. Morbidly ill patients in ICU
2. Psychiatric patients
3. Bad diabetic ulcer wounds which may progress to amputation
4. Patients with a known allergy or hypersensitivity to any of the constituents of the product
5. Immunocompromised Status |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Faster granulation tissue formation and Faster wound healing |
Day 3, 7 and 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced infection rates, decreased inflammation, enhanced moisture management |
Day 3, 7 and 14 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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 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
|
This is a randomized parallel group, single center open study comparing the conventional amorphous hydrogel and a Novel Topical Gel Formulation Comprising Colloidal Silver Nanoparticles, Aloe Vera Gel, and Chitosan for treatment of ulcers in diabetic patients. The composition of the Novel topical gel are of 25gm of CMC gel and 25gm of carbopol gel mixed using a homogenizer and 5ml of AgNCs+ Aloe vera gel solution added to it. A total of 40 patients are to be included in the study. Primary outcome of the study is faster wound healing and early appearance of granulation tissue. Day 3, 7 and 14 are the time points and photographic evidence is used to assess response to treatment. Secondary outcomes are reduced infection rates, decreased inflammation, enhanced moisture management, enhanced patient comfort and compliance and potential cost savings. |