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.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- A favorable outcome shall be based on complete wound closure within a time frame of 4 weeks.
研究概览
简要总结
A new anti-microbial dressing is been tested in comparison with the standardavailable dressing. As per the currentpractice, Silver coated dressing is been used for dressing in Diabetic footulcers. The participant would be treated with either the Standard Dressing (SD) orthe investigational new anti-microbial dressing (VELVERT) as per therandomization schedule.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
A favorable outcome shall be based on complete wound closure within a time frame of 4 weeks.
时间窗: 4 weeks
A favorable outcome is considered to have occurred in a given patient if all the following composite endpoints are met:
时间窗: 4 weeks
1.To obtain wound closure status on day 28 or earlier.
时间窗: 4 weeks
2.Evaluation of time taken for wound closure assessed through Bates-Jensen Wound Assessment Tool and wound photographs at each visit.
时间窗: 4 weeks
3.Evaluate bacterial load before (Day 0) and on the last day (Day 28)
时间窗: 4 weeks
次要结局
- 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)