Skin Microcirculation in Patients With Lower Limb Atherosclerosis (SMILLA)

August 24, 2026 updated by: ODI Medical AS
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Norway
      • Oslo, Norway
        • Recruiting
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients scheduled for elective PTA
Device: Examination with the ODI-Tech medical device
Diffuse reflectance spectroscopy and computer-assisted microscopy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ODI Medical AS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIV-NO-25-10-054857

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data supporting the results of the study.

IPD Sharing Time Frame

From 6 months after publication of the primary results and until 5 years thereafter.

IPD Sharing Access Criteria

De-identified data will be made available to qualified researchers who submit a scientific and methodologically sound proposal to the sponsor.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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