NCT07312383

Skin Microcirculation in Patients With Lower Limb Atherosclerosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: ODI Medical AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Examination with the ODI-Tech medical device	Diffuse reflectance spectroscopy and computer-assisted microscopy.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: Norway