Skin microcirculation monitoring in people with lower limb atherosclerosis having angioplasty
Skin Microcirculation in Patients With Lower Limb Atherosclerosis
This tests whether the non-invasive ODI-Tech device can track changes in skin blood flow in adults with lower limb atherosclerosis who are having percutaneous transluminal angioplasty.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ODI Medical AS Industry-sponsored |
| Locations | 1 site (Oslo) |
| Trial ID | NCT07312383 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with obstructive infra-inguinal lower limb atherosclerosis and ischemia (Rutherford grade 3–6), an open distal anterior tibial artery, scheduled for elective PTA, and able to give informed consent.
Not a fit: Patients with active skin infection at the measurement sites, those not undergoing PTA, or those with different arterial anatomy than specified may not benefit from the device as tested here.
Why it matters
Potential benefit: If successful, the device could provide a quick, non-invasive way to monitor microvascular recovery after PTA and help guide post-procedure care.
How similar studies have performed: Non-invasive microvascular monitoring methods such as laser Doppler and near-infrared spectroscopy have shown some promise, but use of the ODI-Tech device for this specific application is relatively new.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Inger Hilde Zahl, PhD
- Email: email@odimedical.com
- Phone: +4799798788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.