| CTRI Number |
CTRI/2024/07/070809 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| 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 randomized, Multi centric, study to evaluate the safety and efficacy of Three medical devices used in adjuvant to treat Venous leg ulcer. |
|
Scientific Title of Study
|
An interventional, open label, randomized, three arm comparative, Multi centric, post market clinical study to evaluate the safety and efficacy of medical devices used in adjuvant to the treatment of Venous leg ulcer. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DMPL/CIP-006/2024/CT/VV, 1.0; Date: 16-Apr-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhir Kumar |
| Designation |
HOD Plastic Surgery |
| Affiliation |
HOD Plastic Surgery, MLB hospital, Jhansi |
| Address |
Maharani Laxmi Bai Medical College, Jhansi, U.P.
Jhansi
UTTAR PRADESH
284001
India |
| Phone |
9415073541 |
| Fax |
|
| Email |
drsudhirkumarmlb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddharth Pandey |
| Designation |
VP and R and D Head |
| Affiliation |
Datt Mediproducts Pvt Ltd |
| Address |
52 to 54,63 & 64, Roz Ka Meo Industrial
Area Nuh, Distt. Mewat
Gurgaon
HARYANA
122103
India |
| Phone |
9315829298 |
| Fax |
|
| Email |
siddharth.pandey@dattmedi.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PANKAJ BABLANI |
| Designation |
G M Clinical Research |
| 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 Centre, East of Kailash,
New Delhi, India - 110065 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhir Kumar |
Maharani Laxmi Bai Medical College, Jhansi, U.P. |
Department of Plastic Surgery
Jhansi
UTTAR PRADESH |
9415073541
drsudhirkumarmlb@gmail.com |
| Dr Sandeep Mahapatra |
Nizams Institute of Medical Sciences |
Department of Vascular Surgery
Punjagutta, Hyderabad, Telangana 500082
Hyderabad
TELANGANA |
9948769761
vascular.sandeep@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MLB Medical College, Jhansi |
Approved |
| NIMS Institutional Ethics Committee, Hyadrabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I872||Venous insufficiency (chronic) (peripheral), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
VELFOUR® |
It is a four layered high compression bandage. It is made of Cotton, & Lycra. Elasticity in the bandage provides an excellent fit around the limb. It is indicated to provide high compression in cases of venous leg ulcers
Device (VELFOUR) would be applied every eighth day for 60 days. (08 times) |
| Comparator Agent |
VELSOFT with VELVERT |
Is a light compression 100% Cotton, bandage which is proven to provide a sustained light compression for up to 20 mmHg. It is Indicated as a support bandage in venous leg ulcers, lymphatic disorders & to support muscle pump to eliminate venous stasis. The dressings help to restore VELVERT® at its place and boosting wound healing
Device (Both, VELVERT & VELSOFT) would be applied every fourth day for 60 days. (15 times) |
| Intervention |
VELVERT |
An antimicrobial dressing, indicated as an adjunct for the prevention and treatment of wound caused as a result of Venous leg ulcer.
Device would be applied every fourth day for 60 days. (15 times) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Informed consent from the subject/ or legally authorized representatives (LAR) who is able to read, understand informed consent, and sign the informed consent.
2. Subjects who allow their data to be collected for the study at pre-defined follow-up periods.
3. Adult non-diabetic, patients, with venous ulcers unresponsive to conventional therapy, in the age group of 18 years to 70 years. (Both included)
4. Subjects with ulcers of venous origin, as clinically determined by the investigator by a positive venous reflux test using Doppler ultrasound or Ankle-brachial index, on the day of screening, which have not adequately responded to conventional ulcer therapy.
5. Ulcers that extend through the epidermis but not through muscle, tendon, or bone (Stage II or III ulcers as defined by the IAET).
6. Subjects having active Venous leg ulcer. (Grade C-5 and above)
7. Active Venous Leg Ulcers with Wound area criteria post-debridement between 5 cm2 to and 40 cm2. |
|
| ExclusionCriteria |
| Details |
1. Subjects unwilling or unable to comply with the postoperative visits necessary for data collection
2. Severe clinical infection, highly exuding wounds, active systemic infections, like pus oozing from ulcer site
3. HbA1c level of participant will Greater than and equal to 6.8.
4. The ulcer to be treated requires operative debridement.
Highly exuding wounds (wounds that require a daily dressing change).
5. Subjects with active systemic infections
6. Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer).
7. Subjects with active osteomyelitis or connective tissue disease of the affected foot.
8. Subjects found positive for HIV, HCV, and HBsAg.
9. Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study.
10. Pregnant and nursing (breastfeeding) females.
11. Comorbidities which could interfere with clinical evaluations or interpretation of results.
12. Subjects with known allergy to the constituents of investigational products/ device.
13. Subjects with a severe comorbid disorder, not expected to survive more than 12 months.
14. Previous or current radiation therapy or likelihood to be receive during the trial.
15. Poor adaptivity or seriously ill subjects who cannot finish the observation period.
16. Any other condition which, according to the judgment of the investigator, could interfere in the study.
17. Serum fibrinogen value of more than 700 mg/dl
18. Subjects with Ankle-brachial pressure index (ABPI) less than and equal to 0.8. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Complete wound closure within 60 days.
2. Rate of wound healing, measured by percentage reduction in wound size from baseline to wound healing day or day 60 whichever is earlier.
3. Incidence of wound infection (Assessed by clinical evaluation and microbiological analysis by swab test) from baseline to wound healing day or day 60 whichever is earlier. |
Total duration of the trial is 60 days from the first dressing application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of wound closure rates and pain intensity assessment using a Pain Chart, on a scale of 0-10 Numeric from baseline to wound healing day or day 60 whichever is earlier.
2. Wound showing reduction of ≥ 70% of the initial wound size by day 60.
3. Number of adverse events (related to treatment arms) and wound complications either due to dressing material or other causes.
4. Number of dressings required to achieve complete wound closure. |
Total duration of the trial is 60 days from the first dressing application |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
22/07/2024 |
| Date of Study Completion (India) |
12/11/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The cause of venous ulcers is high pressure in the veins of the lower leg. The veins have one-way valves that keep blood flowing up toward your heart. When these valves become weak or the veins become scarred and blocked, blood can flow backward and pool in your legs. This is called venous insufficiency. This leads to the high pressure in the lower leg veins. The increase in pressure and buildup of fluid prevents nutrients and oxygen from getting to tissues. The lack of nutrients causes cells to die, damaging the tissue, and a wound is form. Venous ulcers are generally irregular, shallow, and located over bony prominences. Granulation tissue and fibrin are typically present in the ulcer base. Associated findings include lower extremity varicosities, edema, venous dermatitis, and Lipodermatosclerosis. Wound dressings are the key components of effective venous leg ulcer treatment. medical adhesive can help the patient be more comfortable and promote rapid healing, By comparing these treatment arms, the study seeks to identify the most effective and safe approach for VLU management. Assessing wound healing rates, infection prevention, patient comfort, and cost-effectiveness will provide valuable insights into the optimal utilization of these interventions. Hence, the findings of this study aim to improve clinical outcomes and quality of life for patients suffering from VLUs, filling critical gaps in current treatment guidelines and practice. |