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CTRI Number  CTRI/2024/10/075593 [Registered on: 22/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A two arm, Assessor blind, clinical study to evaluate safety and efficacy of an antimicrobial wound dressing (VELVERT®) in comparison to a non-silver dressing in treatment of diabetic foot ulcer. 
Scientific Title of Study   A randomized, two arm, single (Assessor) blind, post-marketing clinical follow-up study to evaluate safety and efficacy of a new antimicrobial wound dressing (VELVERT®) in comparison to non-silver dressing in management of diabetic foot ulcer. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
DMPL/CIP-011/2024/CT/VV, Version No.: 1.0 Date: 16-Aug-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudhir Kumar 
Designation  HOD & Professor of Plastic Surgery 
Affiliation  Maharani Laxmi Bai Medical College 
Address  Department of Plastic Surgery, MLB Medical college, Jhansi (U.P)

Jhansi
UTTAR PRADESH
284128
India 
Phone  9415073541  
Fax    
Email  drsudhirkumarmlb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddharth Pandey 
Designation  VP and R & D Head 
Affiliation  Datt Mediproducts Pvt Ltd 
Address  Plot No. 52, 53, 54, 63 and 64 Roz Ka Meo Industrial Area NUH

Gurgaon
HARYANA
122103
India 
Phone  9871011002  
Fax    
Email  siddharth.pandey@dattmedi.com  
 
Details of Contact Person
Public Query  
Name  Dr PANKAJ BABLANI 
Designation  Head Clinical Research Operations 
Affiliation  Datt Mediproducts Pvt Ltd. 
Address  56, Community Center, East of Kailash, New Delhi, Delhi 110065

South
DELHI
110065
India 
Phone  9315785417  
Fax    
Email  pankaj.bablani@dattmedi.com  
 
Source of Monetary or Material Support  
Datt Mediproducts Pvt Ltd 56, Community Centre, East of Kailash, New Delhi, India - 110065 
 
Primary Sponsor  
Name  Datt Mediproducts Pvt Ltd,  
Address  56, Community Center, East of Kailash, New Delhi 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  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 Sudhir Kumar  Maharani Laxmi Bai Medical College  Dept. of Plastic surgery MLB College, Jhansi, Uttar Pradesh 284001
Jhansi
UTTAR PRADESH 		 9415073541

drsudhirkumarmlb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MLB Medical College, Jhansi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E13||Other specified diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Sorbact Dressing  Sorbact Dressing irreversibly binds and inactivates bacteria. The dressing pad has an absorbent core for low-moderate exudate management. It would be applied every 4 days for 60 days followed by a follow-uo on day 90 
Intervention  VELVERT®  Velvert is an antimicrobial dressing that is indicated for use in diabetic foot ulcers. It would be applied every 4 days for 60 days followed by a follow-uo on day 90 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Adult diabetic male or female patients of age group between 18 to 70 years. (Both included).
2. Patient with diabetic foot ulcer Stage 2/3 and non- ischemic
3. Patient with Wagner Grade 1 or 2 (without bone exposure).
4. Patient / LAR must be able to read and understand informed consent and can sign the informed consent on patient’s behalf.
5. Patient who allows their data to be collected for the study at predefined follow-up periods.
6. Ulcer with wound size with area ≥2 cm2
7. HbA1c level in above 6.5% with controlled diabetes. 
 
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 & Lactating 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. Allergies to any material contained investigational devices.
9. Subject with ischemic Diabetic foot ulcer. (by assessing the signs of reduced blood flow to the foot, such as pale or bluish skin color, coolness to the touch, or delayed capillary refill (pressing on the skin and watching how quickly the color returns). These signs indicate that there may be insufficient blood reaching the affected area)
10. Subjects with diabetic foot ulcer complications. (Wagner Grade 3 and above).
11. Subjects with gangrene present on any part of the affected foot.
12. Subjects with infected wound (non-diabetic), burn wounds, malignant ulcers, tubercular ulcers, leprotic ulcers, venous ulcers, gangrenous ulcers, ischemic ulcers, bed sores, other than Diabetic foot ulcers.
13. 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   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Study end points shall be based on reduction in wound size or closure within 60 days.
1. A Complete wound closure within 60 days. 		 Up to 8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1. Reduction in wound size ≥ 75% of the initial wound size.
2. Reduction in wound size to ≥ 90% of the initial wound size. Complete wound closure is defined as complete skin re-epithelialization without drainage.
3. Evaluation of the wound based on Bates-Jensen Wound Assessment Tool (BWAT) score.
4. Evaluation of the wound on the basis of wound photographs.
5. Evaluate on the basis of comparative bacterial load on Day 0 - prior to application of the investigational dressing, visit 09 and at the end of treatment (last day of treatment or Day 60 whichever is earlier) by performing swab test.
6. Number of subjects reporting reduction in pain on the basis of the LIKERT pain scale, level on a 0- 10 Numeric Pain Chart on day of dressing and its final removal 		 90 days 
7. Number of adverse events and wound complications either due to dressing material or other causes till day 90.
8. Assessment for scar size on wound surface area 		 90 days 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   26/10/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 randomized, two arm, Assessor blinded, post-marketing clinical follow-up study to evaluate safety and efficacy of  VELVERT in comparison to non-silver dressing in management of diabetic foot ulcer. 
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