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NCT Number: NCT07312383

Skin Microcirculation in Patients With Lower Limb Atherosclerosis

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.

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Key information

Conditions

Percutaneous Transluminal Angioplasty Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Atherosclerosis of Arteries of the Extremities, Unspecified Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, Norway

Location status: Recruiting

About this study

This clinical investigation is designed as a prospective study of limb skin nutritive capillary perfusion and oxygen extraction in patients with lower limb atherosclerosis and severe symptoms before and following elective PTA.

15 patients with critical lower limb atherosclerosis and ischemia in Rutherford grade 3 - 6 undergoing PTA, as well as 15 healthy case matched controls will be enrolled. Measurements will be performed at baseline, prior to PTA, immediately after PTA, 1 day and 30 days post PTA. Healthy case matched controls will be measured at baseline.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Examination with the ODI-Tech medical device

Device

Diffuse reflectance spectroscopy and computer-assisted microscopy.

Primary outcomes

  1. Changes in skin microvascular oxygen saturation (SmvO2)

    Time frame: From baseline to 40 days post PTA

  2. Changes in functional Capillary Density (FCD)

    Time frame: From baseline to 40 days post PTA.

Secondary outcomes

  1. Incidence of AE/ADE/SAE/SADE/DD

    Time frame: From baseline to 40 days post PTA

Study contacts

Contact information is provided by the study sponsor or research team.

Inger Hilde Zahl, PhD

CONTACT

[email protected]

+4799798788

Sponsors and collaborators

Lead sponsor

ODI Medical AS

Industry

Registry information

Acronym: SMILLA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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