RecruitingNot ApplicableNCT07312383
Skin Microcirculation in Patients With Lower Limb Atherosclerosis
Sponsor
ODI Medical AS
Enrollment
30 participants
Start Date
Dec 15, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The aim of this study is to explore the ability of the non-invasive device ODI-Tech® to monitor changes in microvascular blood flow in patients with lower limb ischemia undergoing the procedure percutaneous transluminal angioplasty (PTA). Microvascular data from patients and healthy case matched controls at baseline will be compared.15 patients and 15 healthy case matched controls will be enrolled.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Age ≥18
- Lower limb atherosclerosis and ischemia in Rutherford grade 3-6
- Obstructive infra-inguinal arterial lesions combined with open distal part of the anterior tibial artery
- Scheduled for elective PTA
- Able to give informed consent
Exclusion Criteria1
- Active skin infection at the region of interest (site to be examined, dorsum of hand and foot)
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DEVICEExamination with the ODI-Tech medical device
Diffuse reflectance spectroscopy and computer-assisted microscopy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07312383