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CTRI Number  CTRI/2022/05/042407 [Registered on: 09/05/2022] Trial Registered Prospectively
Last Modified On: 09/10/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate the usefulness of a new antimicrobial wound dressing (VELVERT) for the treating infected wound in comparison Framycetin cream 1% w/w  
Scientific Title of Study   A randomized-controlled, open label, two arm post market clinical study to evaluate safety and efficacy of a new antimicrobial wound dressing (VELVERT) compared to the standard dressing. (SD) in infected wound. 
Trial Acronym  VELVERT 
Secondary IDs if Any  
Secondary ID  Identifier 
DMPL/CIP-002-2022/CT/VV, Version; 1.0 , Date-07-Mar-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aradhana Singh 
Designation  Assistant Professor  
Affiliation  S.N Medical College, Agra 
Address  Department of Surgery S.N Medical College, Agra

Agra
UTTAR PRADESH
282003
India 
Phone  9412589226  
Fax    
Email  drsingharadhana@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aradhana Singh 
Designation  Assistant Professor  
Affiliation  S.N Medical College, Agra 
Address  Department of Surgery S.N Medical College, Agra

Agra
UTTAR PRADESH
282003
India 
Phone  9412589226  
Fax    
Email  drsingharadhana@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pankaj Bablani 
Designation  Head Clinical Research Operation 
Affiliation  Datt Mediproducts Private Limited 
Address  56, Community Centre, East of Kailash, New Delhi -110065, India

New Delhi
DELHI
110065
India 
Phone  9999059412  
Fax    
Email  clinical@dattmedi.com  
 
Source of Monetary or Material Support  
The trial will be insured and study material support would be provided by the sponsor. The trial would be conducted at S.N Medical college, Agra, U.P  
 
Primary Sponsor  
Name  Datt Mediproducts Private Limited 
Address  56, Community Centre, East of Kailash, New Delhi -110065 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aradhana Singh  S.N medical college  Department of surgery S.N medical college Agra
Agra
UTTAR PRADESH 		 9412589226

drsingharadhana@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee S.N Medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Framycetin cream 1% w/w Framycetin cream dressing consists of a cotton leno-weave fabric, impregnated with a base composed of white soft paraffin, anhydrous lanolin, and 1.0% w/w framycetin sulphate.
2Intervention ArmProcedure-Anti microbial Dressing (Procedure Reference: , Procedure details: Dressing to be done once in 4 days / as per the requirement. )
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Male and female of age group between 18 to 70 years (Adult, Older Adult).
2. Subjects must be able to read and understand informed consent, and sign the informed consent to provide data for the study.
3. Subjects who allow their data to be collected for the study at predefined follow-up periods.
4. Female subject that is willing to take contraceptive pills for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least twelve (12) months prior to enrollment.
5. Subjects suffering from infected wound with size more than 25/30 square centimeter.
6. Subjects having a traumatic infected wound with duration less than 1 month.
 
 
ExclusionCriteria 
Details  1. Subject unwilling or unable to comply with the follow up visits necessary for data collection.
2. Subject found positive for HIV, HBsAg and HCV.
3. Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study.
4. Pregnant females.
5. Subject with Immunosuppression, corticosteroids or chemotherapy.
6. Subject with decision making impairment.
7. Subject with a severe comorbid disorder, not expected to survive more than 12 months.
8. Diabetic foot infections.
9. Allergies to any material contained investigational devices.
10. Subjects with burn wounds, DFU, malignant ulcers, tubercular ulcers, leprotic ulcers, gangrenous ulcers, ischemic ulcers, bed sores.
11. Any other condition which, according to the judgment of the investigator, could interfere in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of dressings and time required (in days) to achieve complete wound closure. Healing is based on Favorable healing outcome (FHO) at a time frame of 24 days.
An FHO is considered to have occurred in a given patient if all the following composite endpoints are met:
I. Total wound area (sum of areas of all present wounds on both limbs) has decreased, compared to baseline (Screening), by 100% at or before the scheduled last visit.
II. Comparative evaluation of wounds through Bates-Jensen Wound Assessment Tool and assessment of wound photographs at each visit.
III. Evaluate bacterial load before (Day 0), Day 8, Day 16 and on the last day (Day 24).
 		 (Day 24).
 
 
Secondary Outcome  
Outcome  TimePoints 
i. Comparative evaluation of wound infection during the study period assessed through TLC and DLC evaluation.
ii. Comparative evaluation of each of the observation used to define FHO at time frame of 24 days.
iii. Comparative evaluation of the number of complete wound closures.
iv. Number of local cares requiring instrumental debridement (surgical or sharp debridement) in 24 days duration.
v. Number of subjects reporting relive from pain Comparative evaluation of Subject pain level based on a 0-10 Numeric Pain Chart on each dressing day and its final removal (0 - no pain, 10 - worst pain imaginable). They will be instructed to share the medication name, dosage, and number of pills if they are given analgesics for pain relief.
vi. Assessment of infection level.
vii. Comparative evaluation of Subject for their infection level based on TLC and DLC values.
 		 24 days  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)
Modification(s)  		 28/06/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A new anti microbial dressing is been tested in comparison with the standard available dressing. As per the current practice, Framycetin cream 1%w/w ointment is been used for dressing in infected wounds. the participant would be treated with either the standard dressing (SD) or the investigational new anti- microbial dressing VELVERT as the randomization schedule. 
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