Skin Microcirculation in Patients With Lower Limb Atherosclerosis

NCT07312383 | Recruiting

• 1 other identifier: CIV-NO-25-10-054857
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Atherosclerosis; Lower leg ischaemia; PTA

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of AE/ADE/SAE/SADE/DD

  From baseline to 40 days post PTA

Study Arms (1)

Patients scheduled for elective PTA

OTHER

Device: Examination with the ODI-Tech medical device

Interventions

Examination with the ODI-Tech medical device DEVICE

Diffuse reflectance spectroscopy and computer-assisted microscopy.

Patients scheduled for elective PTA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• ODI Medical AS: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Related Publications (4)

• Mork C, Kvernebo K, Asker CL, Salerud EG. Reduced skin capillary density during attacks of erythromelalgia implies arteriovenous shunting as pathogenetic mechanism. J Invest Dermatol. 2002 Oct;119(4):949-53. doi: 10.1046/j.1523-1747.2002.00218.x.

  PMID: 12406343 BACKGROUND

• Wester T, Awan ZA, Kvernebo TS, Salerud G, Kvernebo K. Skin microvascular morphology and hemodynamics during treatment with veno-arterial extra-corporeal membrane oxygenation. Clin Hemorheol Microcirc. 2014;56(2):119-31. doi: 10.3233/CH-131670.

  PMID: 23357861 BACKGROUND

• Fredly S, Fugelseth D, Nygaard CS, Salerud EG, Stiris T, Kvernebo K. Noninvasive assessments of oxygen delivery from the microcirculation to skin in hypothermia-treated asphyxiated newborn infants. Pediatr Res. 2016 Jun;79(6):902-6. doi: 10.1038/pr.2016.16. Epub 2016 Feb 8.

  PMID: 26854800 BACKGROUND

• Sundheim LK, Sporastoyl AH, Wester T, Salerud G, Kvernebo K. Acute skin trauma induces hyperemia, but superficial papillary nutritive perfusion remains unchanged. Microcirculation. 2017 Oct;24(7). doi: 10.1111/micc.12389.

  PMID: 28632939 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Inger Hilde Zahl, PhD

CONTACT

+4799798788; email@odimedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: December 15, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: From 6 months after publication of the primary results and until 5 years thereafter.
• Access Criteria: De-identified data will be made available to qualified researchers who submit a scientific and methodologically sound proposal to the sponsor.

Locations

NO (1)