NL-OMON52202招募中不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 55 years and older
- •- Scheduled for a recanalization/bypass operation
- •- Written informed consent.
- •- Claudication, Rutherford class 4-6.
- •- Healthy skin of the affected limb
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.
- •- Tattoos in location of patches.
- •- Anyone who is unable to lie supine on their back.
- •- Known hypersensitivity to the active substance or any of the following
- •excipients: patches: 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.
- •- Previous photodynamic therapy or recent use of a tanning bed.
- •- Subjects using medicinal products with known phototoxic or photoallergic
- •potential such as St. John's wort, griseofulvin, thiazide diuretics,
- •sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines.
- •- Use of other topical medicinal products.
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