Health Condition 1: E13- Other specified diabetes mellitus
Conditions
Interventions
Intervention1: 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 p
Sponsors
Datt Mediproducts Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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).
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Pankaj Bablani
Datt Mediproducts Private Limited
Outcome results
None listed