EUCTR2021-004870-78-NL进行中（未招募）1 期
Detecting mitochondrial oxygen tension (mitoPO2) as a measure of local tissue oxygenation in patients with various stages of PAD with the Cellular Oxygen Metabolism (COMET) measurement system of Photonics Healthcare B.V. - A pilot study - COMPASIO
niversity Medical Centre Groningen0 个研究点目标入组 20 人开始时间: 2021年10月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-55 years and older.
- •-Written informed consent.
- •-Claudication, Rutherford class 4-6.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •-Insufficient knowledge of the Dutch language, illiteracy, or language barrier.
- •-Lower leg fracture within the past 12 months.
- •-(Partial) amputation of one of the feet and/or legs.
- •-Pregnant or breastfeeding.
- •-Severe peripheral oedema and/or skin defects.
- •-Severe cardiac-pulmonary failure.
- •-Active cellulitis-erysipelas of the legs or other dermatological diseases.
- •-Known hypersensitivity to the active substance or any of the following excepients: plasters: acrylic pressure sensitive adhesive (poly[(2-ethylhexyl)acrylate-co-methylacrylate-co-acrylic acid-co-glycidylmethacrylate]), backing film: pigmented polyethylene aluminium vapor coated polyester, and release liner (polyethylene terephthalate film) which is removed prior to application.
- •-Known diagnosis of porphyria.
- •-Known photodermatoses of varying pathology and frequency, e.g. metabolic disorders such as aminoaciduria, idiopathic or immunological disorders such as polymorphic light reaction, genetic disorders such as xeroderma pigmentosum, and diseases precipitated or aggravated by exposure to sun light such as lupus erythematoides or phemphigus erythematoides.
- •-Diabetes.
- •There will be no exclusion based on skin colour. Previous studies have confirmed that the device works with all skin colours and is not dependent on it.
- •Patients will be asked if they have any known hypersensitivity.
- •Photodermatosis has a clear profile. We will check patients’ medical history and will ask all subjects explicitly.
- •Patients with PAD have more comorbidities, and often suffer from diabetes, cardiac and pulmonary diseases. A major complication of CLTI in combination with diabetes are non-healing ulcers of the lower extremity.
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