Skin Microcirculation in Patients With Lower Limb Atherosclerosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorODI Medical AS

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Active skin infection at the region of interest (site to be examined, dorsum of hand and foot)

Trial design

Treatments tested in this trial

  • Examination with the ODI-Tech medical device

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators