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
- Conditions
- 1000318410003216PADPeripheral arterial disease
- Registration Number
- NL-OMON52202
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
- 55 years and older
- Scheduled for a recanalization/bypass operation
- Written informed consent.
- Claudication, Rutherford class 4-6.
- Healthy skin of the affected limb
- 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main endpoint of this pilot study is the occurrence of itching,<br /><br>irritation/pain, or wounds at the site of the patch, and the feasibility of<br /><br>COMET measurements to determine tissue perfusion in the lower extremity in<br /><br>patients with moderate to severe claudication (Rutherford class 4-6) assessed<br /><br>by display of the measurements on the COMET monitor with sufficient signal<br /><br>quality. The verbal rating scale (VRS)31 will be used to assess itching. It is<br /><br>a 5-point Likert scale in which patients are asked to categorize their pruritus<br /><br>(0= *no itch,* 1= *weak itch,* 2= *moderate itch,* 3= *severe itch*, 4= *very<br /><br>severe itch*). Irritation, pain, and wounds will be assessed visually and via<br /><br>standardised questionnaires.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Standardized and optimal measurement protocol in terms of location and time<br /><br>in patients with moderate to severe claudication (Rutherford class 4-6) through<br /><br>comparing signal quality at different locations and time points<br /><br>• COMET measurements in correlation with tcPO2 and ABI<br /><br>• Signal quality in the same place of the Alacare patch after previous use<br /><br>• Effect of skin temperature on COMET measurements</p><br>