RecruitingNot Applicable

Skin Microcirculation in Patients With Lower Limb Atherosclerosis

Norway30 participantsStarted 2025-12-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Changes in skin microvascular oxygen saturation (SmvO2)

Timeframe: From baseline to 40 days post PTA

Changes in functional Capillary Density (FCD)

Timeframe: From baseline to 40 days post PTA.

Trial details

NCT IDNCT07312383

SponsorODI Medical AS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

Inger Hilde Zahl, PhD

+4799798788 email@odimedical.com

View on ClinicalTrials.gov More Percutaneous Transluminal Angioplasty trials