Skin Microcirculation in Patients With Lower Limb Atherosclerosis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07312383

Acronym

SMILLA

Enrollment

Registered

2025-12-31

Start date

2025-12-15

Completion date

2026-12-01

Last updated

2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis of Arteries of the Extremities, Unspecified, Percutaneous Transluminal Angioplasty

Keywords

Atherosclerosis, Lower leg ischaemia, PTA

Brief 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.

Detailed description

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.

Interventions

DEVICEExamination with the ODI-Tech medical device

Diffuse reflectance spectroscopy and computer-assisted microscopy.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Changes in skin microvascular oxygen saturation (SmvO2)	From baseline to 40 days post PTA
Changes in functional Capillary Density (FCD)	From baseline to 40 days post PTA.

Secondary

Measure	Time frame
Incidence of AE/ADE/SAE/SADE/DD	From baseline to 40 days post PTA

Countries

Norway

Contacts

CONTACTInger Hilde Zahl, PhD

email@odimedical.com+4799798788

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026