| CTRI Number |
CTRI/2023/03/050554 [Registered on: 10/03/2023] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the effectiveness of a new antimicrobial wound dressing (VELVERT) in diabetic foot ulcer. |
|
Scientific Title of Study
|
A non-randomized, open label, single arm post market clinical study to evaluate effectiveness of a new antimicrobial wound dressing (VELVERT) in diabetic foot ulcer. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| DMPL/CIP-004-2022/CT/VV; Version 1.0; Date 29-Aug-2022 |
Protocol Number |
| DMPL/CIP-004-2022/CT/VV; Version 3.0 Date: 31-May-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Brijesh Sharma |
| Designation |
Assistant professor |
| Affiliation |
S.N. Medical College |
| Address |
Department of Orthopedic,
S.N. Medical College,
Moti Katra
Agra
UTTAR PRADESH
282003
India |
| Phone |
9412286111 |
| Fax |
|
| Email |
bsharma1711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddharth Pandey |
| Designation |
Vice President (R&D) |
| Affiliation |
Datt Mediproducts Private Limited |
| Address |
56 community center,
East of Kailash
South
DELHI
110065
India |
| Phone |
9871011002 |
| Fax |
|
| Email |
lifescience@dattmedi.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Bablani |
| Designation |
General Manager Clinical Research |
| Affiliation |
Datt Mediproducts Private Limited |
| Address |
56 community center,
East of Kailash
South
DELHI
110065
India |
| Phone |
9315785417 |
| Fax |
|
| Email |
pankaj.bablani@dattmedi.com |
|
|
Source of Monetary or Material Support
|
| The clinical trial is been conducted in the department of Orthopedics, S.N medical college, Agra, and is covered under Clinical trial insurance. The monetary support is been provided by the sponsor. (Datt Mediproducts Pvt. Ltd.) |
|
|
Primary Sponsor
|
| Name |
Datt Mediproducts Private Limited |
| Address |
56 community center,
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 Brijesh Sharma |
S.N. Medical College |
Department of Orthopedic
S.N. Medical College,
Moti Katra
Agra
UTTAR PRADESH |
09412286111
bsharma1711@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Agra |
Approved |
| Institutional Ethics Committee, S.N Medical College, Agra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E13||Other specified diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
VELVERT an anti-microbial dressing |
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
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult Diabetic male and female subjects of age group between 18 to 65 years. (Both included).
2. Subjects with Diabetic foot ulcer Stage 2/3, Non- ischemic.
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.
5. Subject has adequate vascular perfusion of the affected limb, as defined by - Ankle-Brachial Index (ABI) greater than equal to 0.9 and less than equal to 1.2
6. Ulcer with a size greater than equal to 04 to less than equal to 18 cm (length and breadth) and depth less than equal to 2 cm.
7. HbA1c greater than equal to 6.5% (diabetic patients). |
|
| 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. Allergies to any material contained investigational devices.
9. Subject with ischemic Diabetic foot ulcer.
10. Subjects with diabetic foot ulcer complications. (Stage 3 and above).
11. Subjects with gangrene present on any part of the affected foot.
12. Subjects with burn wounds, malignant ulcers, tubercular ulcers, leprotic ulcers, venous ulcers, gangrenous ulcers, ischemic ulcers, and bed sores.
13. Subjects with infected wound, not related to Diabetic foot ulcers.
14. Any other condition which, according to the judgment of the investigator, could interfere in the study.
15. Restricted blood flow studied through Doppler test. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. To study reduction in wound size on day 28.
2. Evaluation of change in wound size through Bates-Jensen Wound Assessment Tool and wound photographs on schedule visits.
3. Evaluate bacterial load before application of the dressing and at end of study.(Day 28) |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Days taken to attain healthy granulation tissues.
2. Number of subjects reporting relief from pain Comparative evaluation of subjects will record their subjective pain level on a 0- 10 Numeric Pain Chart on day of dressing and its final removal (0isno pain, 10 is 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 infection levels through TLC and DLC values. |
28 days |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
13/03/2023 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
VELVERT is an antimicrobial
dressing, manufactured by Datt Mediproducts Private Limited. It is indicated
for dressing in diabetic foot ulcer. The dressing is recommended to be changed
every four day or earlier, if required. It is an antimicrobial dressing,
indicated as an adjunct for the prevention and treatment of wound caused by
Diabetic foot ulcers.
The rationale of this study is
to assess the effectiveness of VELVERT used in Diabetic foot ulcer.
|