Peripheral arterial occlusive disease (PAOD)
Conditions
Interventions
None listed
Sponsors
University Medical Centre Groningen
Eligibility
Inclusion criteria
Inclusion criteria: - 55 years and older - Scheduled for a recanalization/bypass operation - Written informed consent. - Claudication, Rutherford class 4-6. - Healthy skin of the affected limb
Exclusion criteria
Exclusion criteria: - 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. - Severe cardiac-pulmonary failure. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility and tolerability of mitochondrial oxygenation measurements with the COMET device and Alacare patch in patients with severe claudication (Rutherford class 4-6). | — |
Secondary
| Measure | Time frame |
|---|---|
| • the optimal measurement location for the measurement of mitochondrial oxygen consumption with the best signal quality. • the influence of application time for the Alacare patch on the signal quality. • correlation of the COMET device measurements to TcPO2 and ankle brachial index (ABI) • signal quality in the same place of the Alacare patch after previous use. • effect of skin temperature on COMET measurements | — |
Contacts
Public ContactAbdallah Hussam Abdallah Zaid Al-Kaylani
University Medical Centre Groningen
Outcome results
None listed