Health Condition 1: E139- Other specified diabetes mellituswithout complications
Conditions
Interventions
None listed
Sponsors
Datt Mediproduct Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult Diabetic male and female subjects of age group between 30 to 70 years. (Both included) 2.Subjects with Diabetic foot ulcer Stage 2/3, Non- ischaemic. 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
Exclusion criteria
Exclusion criteria: 1.Subjects unwilling or unable to comply with the postoperative visits necessary for data collection 2.Subjects found positive for HIV and HPV 3.Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study 4.Pregnant females 5.Comorbidities which could interfere with clinical evaluations or interpretation of results 6.Subjects with known allergy to the constituents of investigational products/ device. 7.Subjects with immunosuppression, corticosteroids or chemotherapy 8.Subjects with a severe comorbid disorder, not expected to survive more than 12 months. 9.Poor adaptivity or seriously ill subjects who cannot finish the observation period. 10.Any other condition which, according to the judgment of the investigator, could interfere in the study. 11.Subject with ischemic Diabetic foot ulcer, Infected wound, Second-degree burn. 12.Subjects with diabetic foot ulcer complications. (Stage 3 and above) 13.Subjects with gangrene present on any part of the affected foot.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A favorable outcome shall be based on complete wound closure within a time frame of 4 weeks. A favorable outcome is considered to have occurred in a given patient if all the following composite endpoints are met: 1.To obtain wound closure status on day 28 or earlier. 2.Evaluation of time taken for wound closure assessed through Bates-Jensen Wound Assessment Tool and wound photographs at each visit. 3.Evaluate bacterial load before (Day 0) and on the last day (Day 28) Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Comparative evaluation VELVERT vs Standard dressing in number of days for a complete wound closure by 4 weeks 2 Number of subjects reporting relief from pain Comparative evaluation of subjects will record their subjective pain level on 0 to 10 Numeric Pain Chart on day of dressing and its final removal 0 for no pain 10 for 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 TLC and DLC values 5 Assessment of Swab test of the wound site 6 Number of dressings required to achieve complete wound closure Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr Pankaj Bablani
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Outcome results
None listed