Health Condition 1: E13- Other specified diabetes mellitus
Conditions
Interventions
Intervention1: VELVERT®: Velvert is an antimicrobial dressing that is indicated for use in diabetic foot ulcers. It would be applied every 4 days for 60 days followed by a follow-uo on day 90
Control
Sponsors
Datt Mediproducts Pvt Ltd,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult diabetic male or female patients of age group between 18 to 70 years. (Both included). 2. Patient with diabetic foot ulcer Stage 2/3 and non- ischemic 3. Patient with Wagner Grade 1 or 2 (without bone exposure). 4. Patient / LAR must be able to read and understand informed consent and can sign the informed consent on patient’s behalf. 5. Patient who allows their data to be collected for the study at predefined follow-up periods. 6. Ulcer with wound size with area =2 cm2 7. HbA1c level in above 6.5% with controlled diabetes.
Exclusion criteria
Exclusion criteria: 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 & Lactating 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. (by assessing the signs of reduced blood flow to the foot, such as pale or bluish skin color, coolness to the touch, or delayed capillary refill (pressing on the skin and watching how quickly the color returns). These signs indicate that there may be insufficient blood reaching the affected area) 10. Subjects with diabetic foot ulcer complications. (Wagner Grade 3 and above). 11. Subjects with gangrene present on any part of the affected foot. 12. Subjects with infected wound (non-diabetic), burn wounds, malignant ulcers, tubercular ulcers, leprotic ulcers, venous ulcers, gangrenous ulcers, ischemic ulcers, bed sores, other than Diabetic foot ulcers. 13. Any other condition which, according to the judgment of the investigator, could interfere in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study end points shall be based on reduction in wound size or closure within 60 days. 1. A Complete wound closure within 60 days.Timepoint: Up to 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in wound size = 75% of the initial wound size. 2. Reduction in wound size to = 90% of the initial wound size. Complete wound closure is defined as complete skin re-epithelialization without drainage. 3. Evaluation of the wound based on Bates-Jensen Wound Assessment Tool (BWAT) score. 4. Evaluation of the wound on the basis of wound photographs. 5. Evaluate on the basis of comparative bacterial load on Day 0 - prior to application of the investigational dressing, visit 09 and at the end of treatment (last day of treatment or Day 60 whichever is earlier) by performing swab test. 6. Number of subjects reporting reduction in pain on the basis of the LIKERT pain scale, level on a 0- 10 Numeric Pain Chart on day of dressing and its final removalTimepoint: 90 days;7. Number of adverse events and wound complications either due to dressing material or other causes till day 90. 8. Assessment for scar size on wound surface areaTimepoint: 90 days | — |
Countries
India
Contacts
Public ContactDr PANKAJ BABLANI
Datt Mediproducts Pvt Ltd
Outcome results
None listed