CTRI/2024/10/075593招募中Unknown
A randomized, two arm, single (Assessor) blind, post-marketing clinical follow-up study to evaluate safety and efficacy of a new antimicrobial wound dressing (VELVERT®) in comparison to non-silver dressing in management of diabetic foot ulcer.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Study end points shall be based on reduction in wound size or closure within 60 days.
研究概览
简要总结
This is randomized, two arm, Assessor blinded, post-marketing clinical follow-up study to evaluate safety and efficacy of VELVERT in comparison to non-silver dressing in management of diabetic foot ulcer.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult diabetic male or female patients of age group between 18 to 70 years.
- •(Both included).
- •Patient with diabetic foot ulcer Stage 2/3 and non- ischemic
- •Patient with Wagner Grade 1 or 2 (without bone exposure).
- •Patient / LAR must be able to read and understand informed consent and can sign the informed consent on patient’s behalf.
- •Patient who allows their data to be collected for the study at predefined follow-up periods.
- •Ulcer with wound size with area ≥2 cm2
- •HbA1c level in above 6.5% with controlled diabetes.
排除标准
- •Subject unwilling or unable to comply with the follow up visits necessary for data collection.
- •Subject found positive for HIV, HBsAg and HCV.
- •Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study.
- •Pregnant & Lactating females.
- •Subject with Immunosuppression, corticosteroids or chemotherapy.
- •Subject with decision making impairment.
- •Subject with a severe comorbid disorder, not expected to survive more than 12 months.
- •Allergies to any material contained investigational devices.
- •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)
- •Subjects with diabetic foot ulcer complications.
- •(Wagner Grade 3 and above).
- •Subjects with gangrene present on any part of the affected foot.
- •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.
- •Any other condition which, according to the judgment of the investigator, could interfere in the study.
结局指标
主要结局
Study end points shall be based on reduction in wound size or closure within 60 days.
时间窗: Up to 8 weeks
1. A Complete wound closure within 60 days.
时间窗: Up to 8 weeks
次要结局
- 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.)
- 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 area)
研究者
Dr Sudhir Kumar
Maharani Laxmi Bai Medical College
研究点 (1)
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