Skin microcirculation monitoring in people with lower limb atherosclerosis having angioplasty

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective study will use the ODI-Tech non-invasive device to measure skin capillary perfusion and oxygen extraction in 15 patients with severe lower limb atherosclerosis (Rutherford grade 3–6) undergoing elective PTA and in 15 healthy case-matched controls. Patient measurements will be taken at baseline before PTA, immediately after PTA, 1 day post-procedure, and 30 days post-procedure, while controls are measured at baseline. The design compares microvascular parameters between patients and controls and tracks within-patient changes over time after revascularization. The goal is to see if ODI-Tech detects immediate and short-term improvements in skin microcirculation following PTA.

Why it matters

Who can join: the full rules

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)

Where it's running

• Oslo University Hospital
  Oslo, Norway Recruiting

Study contacts

• Study coordinator: Inger Hilde Zahl, PhD
• Email: email@odimedical.com
• Phone: +4799798788

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.