Laser speckle imaging to monitor leg perfusion before, during and after revascularization
SPECTATOR: Perfusion Monitoring Before, During and After Lower Extremity Revascularization With Laser Speckle Contrast Imaging
This study tries a non-invasive laser speckle imaging method to see if it can measure blood flow in the legs of people having lower-extremity revascularization.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, South Holland) |
| Trial ID | NCT07558174 on ClinicalTrials.gov |
What this trial studies
This observational study will use laser speckle contrast imaging (LSCI) to record real-time perfusion of the lower limb before, during, and after revascularization procedures. LSCI measurements will be performed perioperatively and compared with standard indocyanine green near-infrared fluorescence (ICG NIRF) and temperature readings to explore correlations. Participants are patients scheduled for lower-extremity revascularization at Leiden University Medical Center who undergo pre- and postoperative ICG NIRF imaging. The study aims to test feasibility and signal quality of LSCI as a quick, dye-free alternative for bedside perfusion monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for lower-extremity revascularization at Leiden University Medical Center who will have pre- and postoperative ICG NIRF measurements and can give informed consent.
Not a fit: Patients who are not undergoing revascularization, cannot undergo ICG NIRF imaging as required by the protocol, or have medical conditions judged by investigators to jeopardize safety are unlikely to benefit.
Why it matters
Potential benefit: If successful, LSCI could offer a quick, non-invasive way to visualize limb perfusion during revascularization and help surgeons predict or improve outcomes without dye injection.
How similar studies have performed: ICG NIRF has shown promise for guiding revascularization, but LSCI is a newer, non-invasive modality with limited prior clinical validation in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled for lower-extremity revascularization * Undergoing pre- and postoperative indocyanine near-infrared fluorescence perfusion measurements Exclusion Criteria: Any condition that the investigator considers to be potentially jeopardizing the patient's wellbeing or the study objectives
Where this trial is running
Leiden, South Holland
- Leiden University Medical Center — Leiden, South Holland, Netherlands (Recruiting)
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.