NCT05763654招募中不适用
Multicenter, Long-term, Single-arm and Observational PMCF Study on the Safety of Linovera Emulsion for the Prevention of Stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers (PRELINEM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
To assess the safety of Linovera® Emulsion in the prevention of Grade I Pressure ulcers, Vascular and Diabetic Foot Ulcers.
To assess the performance of Linovera® Emulsion for the prevention of stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers.
详细描述
Diverse parameters are to be used to assess the safety and efficacy of Linovera® Emulsion for the prevention of stage 1 pressure ulcer, vascular and diabetic foot ulcers.
This study is designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity as a part of our Post Market Surveillance (PMS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Signed informed consent
- •Patients with the possibility to participate during up 6 month follow-up.
- •At least one of these criteria:
- •Patients with medium, high or very high risk of amputation due to a vascular or diabetic foot illness.
- •Patients with medium, high or very high risk of developing a pressure ulcer due to any neuropathic foot pathology
- •Patients with medium, high or very high risk of developing a pressure ulcer following Braden Scale.
排除标准
- •Age < 18 years
- •Known allergies and/or hypersensitivity to any component of Linovera® Emulsion.
- •Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures.
- •Patients in the terminal stage or receiving chemotherapy.
- •Patients with more than 3 active pressure ulcers.
结局指标
主要结局
Number of adverse events
时间窗: 1 month
Number of adverse events
次要结局
- Number of participant developing stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers(1 month)
研究者
研究点 (1)
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