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CTRI Number  CTRI/2021/12/038436 [Registered on: 06/12/2021] Trial Registered Prospectively
Last Modified On: 01/01/2024
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   A randomized open label, compared study to evaluate safety and efficacy of a New antimicrobial wound dressing (VELVERT) with a Standard dressing (SD) in patients with infected wound. 
Scientific Title of Study   A randomized-controlled, open label, two arm study to evaluate safety and efficacy of a New antimicrobial wound dressing (VELVERT) compared to the Standard dressing (SD) in infected wound. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DMPL/CIP-01-2020/CT/VV  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vishal Mago 
Designation  Professor in the Department of Plastic Surgery 
Affiliation  All India Institute of Medical Sciences  
Address  AIIMS, Virbhadra Road Shivaji Nagar, near Barrage, Sturida Colony, Rishikesh, Uttarakhand 249203.
Department of Plastic surgery, AIIMS, Rishikesh.
Dehradun
UTTARANCHAL
249203
India 
Phone  9812342588  
Fax    
Email  drvishalm@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vishal Mago 
Designation  Professor in the Department of Plastic Surgery 
Affiliation  All India Institute of Medical Sciences 
Address  AIIMS, Virbhadra Road Shivaji Nagar, near Barrage, Sturida Colony, Rishikesh, Uttarakhand 249203.
Department of Plastic surgery, AIIMS, Rishikesh.
Dehradun
UTTARANCHAL
249203
India 
Phone  9812342588  
Fax    
Email  drvishalm@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Pankaj Bablani 
Designation  Head Clinical Research Operations 
Affiliation  Datt Mediproducts Pvt. Ltd 
Address  56, Community Centre, East of Kailash, New Delhi-110065

South
DELHI
110065
India 
Phone  011-47191777  
Fax    
Email  clinical@dattmedi.com  
 
Source of Monetary or Material Support  
The clinical trial is insured and the monetary support will be given by the sponsor. 
The trial will be conducted in the department of Plastic srgery, AIIMS, Rishikesh. 
 
Primary Sponsor  
Name  Datt Mediproduct Pvt Ltd 
Address  56, Community Centre, East of Kailash, New Delhi- 110065 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None  N/Ap 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vishal Mago  AIIMS, Rishikesh  Department of Plastic surgery AIIMS Rishikesh, Uttarakhand 249203-India
Dehradun
UTTARANCHAL 		 9812342588

drvishalm@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: Infected wound,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Paraffin gauze DressingParaffin gauze Dressing would be used as per the scheduled visits for dressing or as per the requirement in the trial subject. The scheduled visit are captured in the protocol.
2Intervention ArmDrugOther than Classical(1) Medicine Name: VELVERT, Reference: NA, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(NA), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 4 Days, anupAna/sahapAna: No, Additional Information: VELVERT is a soft non-adherent topical wound dressing which is impregnated with antimicrobial formulation derived from plants. It has biocompatible polymeric matrix composed of polyelectrolyte complex of gelatin and chitosan, impregnated with the antimicrobial formulation derived from extracts of Curcuma longa, Phyllanthus emblica and Camellia sinensis
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subject with cellulitis, necrotizing fasciitis, venous ulcer, and bedsores.
2. Subjects with Infected wounds with or without trauma.
3. Male and female of age group between 18 to 70 years (Adult, Older Adult).
4. Subjects must be able to read and understand informed consent and sign the informed consent to provide data for the study.
5. Subjects who allow their data to be collected for the study at predefined follow-up
periods. 
 
ExclusionCriteria 
Details  Subject unwilling or unable to comply with the follow up visits necessary for data
collection.
2. Subject found positive for HIV and HPV.
3. Concurrent participation in another clinical trial that involves an investigational
drug or dressing that would interfere with This Study.
4. Pregnant females.
5. Subjects with osteomyelitis of the underlying bone.
6. Subject with Immunosuppression, corticosteroids or chemotherapy.
7. Subject with Diabetic foot ulcer and/or burn.
8. Patient with a severe comorbid disorder, not expected to survive more than
12 months. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
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 from
the first application of dressing.
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) Comparative evaluation of wound infection during the study period assessed
through TLC and DLC evaluation.
iv) Visual Analogue scale for pain assessment 		 Schedule mentioned in the protocol up to 24 days from
the first application of dressing 
 
Secondary Outcome  
Outcome  TimePoints 
i) Comparative evaluation of each of the observation used to define FHO at time frame of 24 days from the first application of dressing. ii) Comparative evaluation of the number of complete wound closures. iii) Number of local cares requiring instrumental debridement (surgical or sharp debridement) in 24 days duration. iv) 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. v) Assessment of infection level Comparative evaluation of Subject for their infection level based on TLC & DLC value.  24 days from the first dressing application. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   03/01/2022 
Date of Study Completion (India) 20/01/2024 
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   The outcome of the trial would be published on the bases of the CSR. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study is been conducted to assess the efficacy of a new anti-microbial wound dressing (VELVERT) with the standard dressing used (Paraffin gauze dressings) in an infected wound on the basis of its healing rate on clinical evaluation and wound photograph analysis.  
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