Clinical Evaluation of URGOSTART PLUS® BORDER, URGOSTART PLUS® PAD and URGOSTART INTERFACE® in the Local Treatment of Diabetic Foot Ulcers and Venous Leg Ulcer of Mixed Etiology : French Prospective and Multicentric Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Number of patients with complete healed chronic wound (venous leg ulcer and Diabetic foot ulcer) at 12 weeks
研究概览
简要总结
The objective of this study is to document the performance and the safety of UrgoStart Plus® Border, UrgoStart Plus® Pad and UrgoStart Interface® in the local treatment of diabetic foot ulcers (neuropathic or neuroischemic - non-critical ischemia) and venous or mixed predominantly venous leg ulcers, in real life conditions and current practice, in France.
详细描述
This is an observational, non-interventional, prospective multicenter study, carried out in real-life conditions on CE marked medical devices used for their intended purpose.
The study will be carried out in France, in accordance with national and European regulations (RDM 2017/745).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult outpatient having signed informed consent
- •Patient with a venous leg ulcer (VLU) Or with a diabetic foot ulcer (DFU)
- •Prescription of one of the 3 dressings: UrgoStart Plus® Border, UrgoStart Plus® pad or UrgoStart Interface®
- •Patient can be followed over 12 weeks by the investigator, according to his/her practices
- •Patient able to participate in the study and complete a self-questionnaire without difficulty
排除标准
- •Hemorrhagic wound
- •Cancerous wound
- •Fistulous wound revealing a deep abscess
- •Presence of dry necrosis partially or completely covering the wound bed
- •Infected wound
- •Critical or acute ischemia
- •Patient for whom a surgical procedure related to the treated wound is scheduled within 12 weeks following the inclusion visit
- •Patient with known sensitivity to one of the studied dressings components
- •Pregnant or breastfeeding patient
- •Patient under the protection of justice or under guardianship or deprived of liberty
结局指标
主要结局
Number of patients with complete healed chronic wound (venous leg ulcer and Diabetic foot ulcer) at 12 weeks
时间窗: 12 weeks
Complete ulcer closure (100% re-epithelialization) over 12 weeks of treatment with UrgoStart Plus® Border, UrgoStart Plus® pad and UrgoStart Interface® dressings
次要结局
- Time to wound closure(12 weeks)
- EQ5D5L quality of life questionnaire(12 weeks)
- Relative reduction in wound surface area(12 weeks)
- Tolerance : the nature and number of adverse event related to the use of the testing dressings(12 weeks)
- Defectuosity of the device(12 weeks)