A clinical study to observe the safety and effectiveness of VELVERT (a new antimicrobial) wound dressing in treatment of venous leg ulcer.
- Conditions
- Health Condition 1: I830- Varicose veins of lower extremities with ulcer
- Registration Number
- CTRI/2023/10/058211
- Lead Sponsor
- Datt Mediproducts Pvt. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 22
1. Adult male or female subjects within the age group of 18-70 years (Both included).
2. Subject with HbA1c level below 7.5% (well-controlled diabetes mellitus may be permitted).
3. Subject or their LAR, who is able to read and understand informed consent document, and ready to provide signed written Informed Consent document for data collection at pre-defined follow-up visits.
4. Subject with ulcers of venous origin, as clinically determined by the investigator by a positive venous reflux test (venous refilling <18 seconds) using Doppler ultrasound on the day of screening. 5. Subject with Ankle-Brachial Pressure Index (ABI) exam’s value of =0.80 in the affected limb.
6. Subject’s ulcers that extend through the epidermis but not through tendon, or bone (Stage II or III (Asymptomatic) ulcers as per IAET definition).
7. Subjects having active Venous leg ulcer of Grade C-5 and above.
8. Venous leg ulcer (VLU) is present on the leg with full thickness but without exposure of deeper tissues (bone or tendon). 9. If Subject have more than one venous leg ulcer, then largest ulcer meeting criteria shall be consider for the study and only one wound will be considered.
Subjects unwilling or unable to comply with the postoperative visits necessary for data collection.
2. Ulcers of Class III: Symptoms with moderate exertion or, Class IV: Symptoms at rest.
3. The ulcer to be treated requires operative debridement.
4. Subject with active systemic infections
5. Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer).
6. Subjects with active osteomyelitis or connective tissue disease of the affected foot.
7. Subjects found positive for HIV (The test reports valid for 6 months before screening).
8. Concurrent participation in another clinical study 9. Female subject with positive Urine Pregnancy Test (UPT) on screening visit 1 or nursing woman.
10. Subject with comorbidities which could interfere with clinical evaluations or interpretation of results.
11. Subjects with known allergy to the constituents of investigational products/ device i.e. VELVERT.
12. Subject on systemic corticosteroids (15 mg/day), or immunosuppressive therapy.
13. Previous or current radiation therapy or likelihood to be received during the study duration.
14. Poor adaptivity or seriously ill subjects who cannot finish the observation period.
15. Any other condition which, according to the judgment of the investigator, could interfere in the study.
16. Subjects with diabetic foot ulcer complications or with gangrene present on any part of the affected leg.
17. Subjects with Ankle-brachial pressure index (ABPI) =0.8
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method An outcome will be considered to have occurred in a given subject if the following composite endpoints are met: <br/ ><br>1. An outcome shall be based on the reduction of wound area within a time frame of 60 days (around 9 weeks). <br/ ><br>2. To obtain wound closure within 60 days or earlier. (Change in wound size)Timepoint: Wound size will be assessed at Day 4, 8,12,16,20,24,28,32, 36, 40,44,48,52, 56 and Day 60
- Secondary Outcome Measures
Name Time Method umber of patients achieve a complete wound closure or reduction in wound area by more than 80% by 60 days or earlier. (Complete wound closure will be defined as 100% epithelialization of the wound and the absence of drainage from the wound, that is Change in wound area. <br/ ><br>Subject self-assessment of intensity of pain. (Pain scale from 0 to 5) <br/ ><br>Comparative evaluation of subjects will record their subjective pain level on a scale of 0-10 Numeric Pain Chart (VAS) on day of dressing and its final removal (0 no pain, 10 worst pain imaginable) <br/ ><br>Number of adverse events and wound complications either due to dressing material or other causes. (AE reported) <br/ ><br>Number of dressings required to achieve complete wound closure or till last day of study w.r.t. wound area <br/ ><br>Presence of micro-organism load on the last day of visit (Day 60 or earlier) (SWAB testTimepoint: 60 days