NCT03021811已完成不适用
EUREKA Italy - The Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management: a Reproducibility Study
KLOX Technologies Inc.0 个研究点目标入组 100 人开始时间: 2015年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Rate of complete wound closure
研究概览
简要总结
Multi-center, prospective, interventional, uncontrolled open-label study evaluating the real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg ulcers, diabetic foot ulcers, pressure ulcers).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Signed and dated written informed consent form;
- •Adult patient (at least 18 years old) having received a diagnosis of venous leg ulcer, diabetic foot ulcer or pressure ulcer by the Investigator;
- •The treating physician (investigator) believes the KLOX LumiHeal BioPhotonic System would be an appropriate option;
- •Both male and female patients must be willing to adhere to a medically-accepted birth control method during the course of the study;
- •Willingness to comply with study requirements (visits, treatments, etc.).
排除标准
- •Female pregnant patient (by medical history or as ascertained by a pregnancy test);
- •Breast-feeding female patient;
- •Patients taking drugs/products (e.g., methotrexate, chemotherapy agents) or with conditions (e.g., porphyria) known to induce severe photosensitivity reactions;
- •Patients with known skin hypersensitivity.
研究组 & 干预措施
LumiHeal
Other
Treatment of chronic wounds with KLOX LumiHeal BioPhotonic System
干预措施: KLOX LumiHeal BioPhotonic System (Device)
结局指标
主要结局
Rate of complete wound closure
时间窗: Up to 34 weeks
Adverse events, Serious Adverse Events and Device Incidents
时间窗: Up to 34 weeks
Number of patients with adverse events, serious adverse events and device incidents.
次要结局
- Impact of treatment on Health-related Quality of Life (CWIS questionnaire)(Up to 34 weeks)
- Ease of use by healthcare professionals (questionnaire)(Up to 34 weeks)
- Incidence of wound breakdown, following wound closure(Up to 34 weeks)
- Time to complete wound closure(Up to 34 weeks)
- Wound area reduction over time(Up to 34 weeks)
研究者
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