A randomized, open label, single centre, Post Market Surveillance study to evaluate the efficacy and safety of a new antimicrobial wound dressing (VELVERT) compared to standard dressing (SD) in the treatment of Diabetic foot ulcer. - VELVERT

Datt Mediproduct Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•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

•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.

发起方

Datt Mediproduct Pvt Ltd