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ID
Source
Brief title
Health condition
Peripheral arterial occlusive disease (PAOD)
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
• 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
Background summary
Peripheral arterial disease (PAD) is a progressive, common disease which is often underdiagnosed. Symptoms of PAD range from asymptomatic to chronic limb-threatening ischemia (CLTI). It is a result of impairment of tissue perfusion, which requires effective diagnosis. Current diagnostic methods only detect stenotic lesions of the major arteries but do not measure tissue perfusion. It is essential to determine tissue perfusion as impaired perfusion of oxygenated blood is the direct cause of the aforementioned symptoms. The golden standard to determine tissue perfusion is transcutaneous partial pressure of oxygen (tcPO2) measurements. Unfortunately, this method is not suited for everyday clinical use during interventions, is operator dependent and time consuming. The COMET system is a non-invasive system to locally determine mitochondrial oxygen availability in human skin cells. Increase of the mitochondrial metabolism may be an early/sensitive indicator for procedure success, even if tissue perfusion is still low. Therefore, it might perform better than TcPO2. Furthermore, the measurement can easily be performed by health professionals in-hospital, and during interventions. This enables the use of this method during the complete care process of patients with peripheral arterial disease such as early and even intraoperative detection of improvement or failure of therapy.
Study objective
COMET measurements are feasible in patients with PAOD and the measurements are tolerable.
Study design
Start: 01/11/2021
Inclusion expected to be completed 01/05/2022, maximum by 01/03/2023
For each subject:
1) The day before the operation (first day):
a) Patient is admitted
b) At 20:00 > One of the trained researchers applies the Alacare patches on the patient
c) Patient is monitored in the ward via an SOP that will be given to the ward nurses
2) The day of the operation (second day):
a) At 08:00 > Measurements with COMET device, TcPO2, and ABI
b) Patient undergoes operation
c) At 16:00 > Measurements with COMET device, TcPO2 and ABI
Abdallah Hussam Abdallah Zaid Al-Kaylani
0687827217
a.h.a.zaid.al-kaylani@umcg.nl
Abdallah Hussam Abdallah Zaid Al-Kaylani
0687827217
a.h.a.zaid.al-kaylani@umcg.nl
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
- 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9853 |
| Other | METC UMCG : METc 2021/539 |