| CTRI Number |
CTRI/2022/02/040424 [Registered on: 18/02/2022] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the usefulness of a new antimicrobial wound dressing (VELVERT) for treating diabetic foot ulcer wounds in comparison to the standard dressing (SD) |
|
Scientific Title of Study
|
A randomized, open label, single centre, Post Market Surveillance study to evaluate the efficacy and safety of a new antimicrobial wound dressing (VELVERT) compared to standard dressing (SD) in the treatment of Diabetic foot ulcer. |
| Trial Acronym |
VELVERT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DMPL/CIP-01-2021/CT/VV, Version-1.0, Date-16-Feb-2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gyan Chand |
| Designation |
Professor, Department of Endocrine Surgery |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Endocrenology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9451546353 |
| Fax |
|
| Email |
drgyanchandpgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Chand |
| Designation |
Professor, Department of Endocrine Surgery |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Endocrinology, Sanjay Gandhi Post Graduate Institute of Medical Sciences,
Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9451546353 |
| Fax |
|
| Email |
drgyanchandpgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Bablani |
| Designation |
Head Clinical Operations |
| Affiliation |
Datt Mediproducts Pvt. Ltd |
| Address |
Datt Mediproducts Pvt. Ltd.
56, Community Centre, East of Kailash. New Delhi
South
DELHI
110065
India |
| Phone |
9999059412 |
| Fax |
|
| Email |
clinical@dattmedi.com |
|
|
Source of Monetary or Material Support
|
| The trial will be insured and the study material support would be provided by the sponsor. |
|
|
Primary Sponsor
|
| Name |
Datt Mediproduct Pvt Ltd |
| Address |
56, Community Centre, East of Kailash. New Delhi |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Gyan Chand |
SGPGI, Lucknow. |
Department of Endocrenology, Sanjay Gandhi Institute of Medical Sciences. Lucknow, U.P
Lucknow
UTTAR PRADESH |
9451546353
drgyanchandpgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E139||Other specified diabetes mellituswithout complications. Ayurveda Condition: Diabetic foot ulcer., |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: VELVERT, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 24 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: VELVERT, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 24 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Sliver dressing | Ag Non-Adhesive dressings.
The Ag Non-Adhesive is an absorbent antimicrobial three-layer dressing consisting of the following: A SSD (Silver Sulfadiazine) containing absorbent hydrocellular pad sandwiched between a perforated non-adherent wound contact layer and a waterproof outer film.
Dressing shall be applied on Day 0 (First dressing) and on days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, & 26. The use of dressings is also at the discretion of the investigator. |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult Diabetic male and female subjects of age group between 30 to 70 years. (Both included)
2.Subjects with Diabetic foot ulcer Stage 2/3, Non- ischaemic.
3.Subjects/ LAR must be able to read and understand informed consent, and can sign the informed consent on patient’s behalf.
4.Subjects who allow their data to be collected for the study at predefined follow-up periods |
|
| ExclusionCriteria |
| Details |
1.Subjects unwilling or unable to comply with the postoperative visits necessary for data collection
2.Subjects 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.Comorbidities which could interfere with clinical evaluations or interpretation of results
6.Subjects with known allergy to the constituents of investigational products/ device.
7.Subjects with immunosuppression, corticosteroids or chemotherapy
8.Subjects with a severe comorbid disorder, not expected to survive more than 12 months.
9.Poor adaptivity or seriously ill subjects who cannot finish the observation period.
10.Any other condition which, according to the judgment of the investigator, could interfere in the study.
11.Subject with ischemic Diabetic foot ulcer, Infected wound, Second-degree burn.
12.Subjects with diabetic foot ulcer complications. (Stage 3 and above)
13.Subjects with gangrene present on any part of the affected foot.
|
|
|
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 |
A favorable outcome shall be based on complete wound closure within a time frame of 4 weeks.
A favorable outcome is considered to have occurred in a given patient if all the following composite endpoints are met:
1.To obtain wound closure status on day 28 or earlier.
2.Evaluation of time taken for wound closure assessed through Bates-Jensen Wound Assessment Tool and wound photographs at each visit.
3.Evaluate bacterial load before (Day 0) and on the last day (Day 28)
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Comparative evaluation VELVERT vs Standard dressing in number of days for a complete wound closure by 4 weeks
2 Number of subjects reporting relief from pain Comparative evaluation of subjects will record their subjective pain level on 0 to 10 Numeric Pain Chart on day of dressing and its final removal 0 for no pain 10 for 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
3 Number of adverse events and wound complications either due to dressing material or other causes
4 Assessment of TLC and DLC values
5 Assessment of Swab test of the wound site
6 Number of dressings required to achieve complete wound closure
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/03/2022 |
| 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, Silver coated dressing is been used for dressing in Diabetic foot
ulcers. The participant would be treated with either the Standard Dressing (SD) or
the investigational new anti-microbial dressing (VELVERT) as per the
randomization schedule. |