Peripheral Arterial disease
Conditions
Interventions
Trade Name: Alacare
Product Name: Alacare
Pharmaceutical Form: Cutaneous patch
Sponsors
University Medical Centre Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
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. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the feasibility and safety of mitochondrial oxygenation measurements with the COMET device and Alacare patch in patients with severe claudication (Rutherford class 4-6).;Secondary Objective: The secondary objective(s) are: •To determine the optimal measurement location for the measurement of mitochondrial oxygen consumption with the best signal quality. •To determine the influence of application time for the Alacare patch on the signal quality. •To correlate the COMET device measurements to TcPO2 and ankle brachial index (ABI), and •To determine if signal quality drops after measuring in the place of the same Alacare patch spot. ;Primary end point(s): The main endpoint of this pilot study is the occurrence of itching, irritation/pain, or wounds at the site of the patch, and the feasibility of COMET measurements to determine tissue perfusion in the lower extremity in patients with moderate to severe claudication (Rutherford class 4-6) assessed by display of the measurements on the COMET monitor with sufficient signal quality. The verbal rating scale (VRS)31 will be used to assess itching. It is a 5-point Likert scale in which patients are asked to categorize their pruritus (0= “no itch,” 1= “weak itch,” 2= “moderate itch,” 3= “severe itch”, 4= ”very severe itch”). Irritation, pain, and wounds will be assessed visually and via standardised questionnaires.;Timepoint(s) of evaluation of this end point: Patients' safety will be monitored from the second they apply the Alacare until they leave the hospital. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Standardized and optimal measurement protocol in terms of location and time in patients with moderate to severe claudication (Rutherford class 4-6) through comparing signal quality at different locations and time points • COMET measurements in correlation with tcPO2 and ABI. • Difference in signal quality for the same location under the same Alacare patch at two measurement sessions. ;Timepoint(s) of evaluation of this end point: After the last measurement from the last patient has been concluded. | — |
Countries
Netherlands
Contacts
Public ContactAbdallah Kaylani
University Medical Centre Groningen
Outcome results
None listed