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Skin Microcirculation in Patients With Lower Limb Atherosclerosis

NCT ID: NCT07312383

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Percutaneous Transluminal Angioplasty Atherosclerosis of Arteries of the Extremities, Unspecified

Keywords

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Atherosclerosis Lower leg ischaemia PTA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients scheduled for elective PTA

Group Type OTHER

Examination with the ODI-Tech medical device

Intervention Type DEVICE

Diffuse reflectance spectroscopy and computer-assisted microscopy.

Interventions

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Examination with the ODI-Tech medical device

Diffuse reflectance spectroscopy and computer-assisted microscopy.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ODI Medical AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Inger Hilde Zahl, PhD

Role: CONTACT

Phone: +4799798788

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 12406343 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23357861 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26854800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28632939 (View on PubMed)

Other Identifiers

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CIV-NO-25-10-054857

Identifier Type: -

Identifier Source: org_study_id