Measuring oxygen in skin of patients with peripheral arterial disease with the COMET measurement system

Phase 1

• Conditions: Peripheral Arterial disease; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2021-004870-78-NL
• Lead Sponsor: niversity Medical Centre Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-04
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified