A randomized, Multi centric, study to evaluate the safety and efficacy of Three medical devices used in adjuvant to treat Venous leg ulcer.
- Conditions
- Health Condition 1: I872- Venous insufficiency (chronic) (peripheral)
- Registration Number
- CTRI/2024/07/070809
- Lead Sponsor
- Datt Mediproducts Pvt Ltd,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 be= 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) = 0.8.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Complete wound closure within 60 days. <br/ ><br>2. Rate of wound healing, measured by percentage reduction in wound size from baseline to wound healing day or day 60 whichever is earlier. <br/ ><br>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.Timepoint: Total duration of the trial is 60 days from the first dressing application
- Secondary Outcome Measures
Name Time Method 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. <br/ ><br>2. Wound showing reduction of = 70% of the initial wound size by day 60. <br/ ><br>3. Number of adverse events (related to treatment arms) and wound complications either due to dressing material or other causes. <br/ ><br>4. Number of dressings required to achieve complete wound closure.Timepoint: Total duration of the trial is 60 days from the first dressing application