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Skin Microcirculation in Patients With Lower Limb Atherosclerosis

Sponsor: ODI Medical AS • ClinicalTrials.gov ID: NCT07312383

Registry updated: 2026-08-25

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Description

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.

Interventions

Examination with the ODI-Tech medical device (Device)
Diffuse reflectance spectroscopy and computer-assisted microscopy.

Eligibility criteria

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

Conditions

Percutaneous Transluminal Angioplasty Atherosclerosis of Arteries of the Extremities, Unspecified

Locations

Oslo University Hospital — Oslo, Norway

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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