| CTRI Number |
CTRI/2025/09/094750 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of zinc oxide nanoparticles on wound healing |
|
Scientific Title of Study
|
Randomised controlled trial on effect of Zinc Oxide Nanoparticles on chronic
wounds |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vipul Kumar Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of General Surgery IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8005100548 |
| Fax |
|
| Email |
vipulsrivastava@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vipul Kumar Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of General Surgery IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8005100548 |
| Fax |
|
| Email |
vipulsrivastava@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Vipul Kumar Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of General Surgery IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8005100548 |
| Fax |
|
| Email |
vipulsrivastava@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences BHU Varanasi UP India - 221005 |
|
|
Primary Sponsor
|
| Name |
IOE Grant IMS BHU |
| Address |
Banaras Hindu University Varanasi Uttar Pradesh India-221005 |
| Type of Sponsor |
Government medical college |
|
|
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 Vipul Kumar Srivastava |
IMS BHU |
Room no 114 General Surgery OPD Sir Sunderlal Hospital IMS BHU Varanasi UP India- 221005
Varanasi
UTTAR PRADESH |
8005100548
vipulsrivastava@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IMS BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E135||Other specified diabetes mellituswith circulatory complications, (2) ICD-10 Condition: L891||Pressure ulcer of back, (3) ICD-10 Condition: I832||Varicose veins of lower extremities with both ulcer and inflammation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Application of Placebo gel over chronic wounds with standard of care |
| Intervention |
Zinc oxide nanoparticles |
Application of Zinc oxide nanoparticles in gel form over chronic wounds depending upon the surface area of wound on alternate days upto a maximum of ten weeks or till wound heals whichever is earlier |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients of Chronic wounds (Diabetic foot ulcers, Venous ulcers,
Pressure ulcers) |
|
| ExclusionCriteria |
| Details |
Patient not giving consent
Patient already on other modalities of treatment other than simple dressings (NPWT, Bacteriophage therapy, Electrical stimulations, etc.)
Radiation therapy
Chemotherapy
Hemoglobin less than 10 mg per dL
Pregnant and Lactating females
Patients with lymphedema and lymphangitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the reduction in wound size |
10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the change in level of collagen |
10 weeks |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
06/10/2025 |
| 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="3"
Months="0"
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 study is a randomised controlled trial single blinded to be done on patients of chronic wounds for upto a period of three years or till sample size is achieved whichever is earlier. In this study zinc oxide nanoparticles will be applied on chronic wounds along with placebo in other group and the reduction in wound size would be the primary outcome. Secondary outcome would be the change in levels of collagen in wound tissue. |