Actively Recruiting
SPECTATOR: Perfusion Monitoring Before, During and After Lower Extremity Revascularization With Laser Speckle Contrast Imaging
Led by Leiden University Medical Center · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Laser Speckle Contrast Imaging (LSCI) to monitor blood flow in the lower legs before, during, and after revascularization surgery in adults with peripheral artery disease. This condition involves blocked arteries in the legs, causing symptoms from pain while walking to ulcers. The study aims to see if LSCI is a feasible, non-invasive method for assessing tissue blood flow compared to current techniques, which can be invasive and less practical for outpatient use. Participants will undergo LSCI measurements during the perioperative period and after surgery. The study will compare LSCI results with foot temperature and the standard near-infrared fluorescence imaging using indocyanine green dye. The researchers will also explore new ways to analyze LSCI data, such as measuring blood flow pulsatility, to better understand perfusion changes related to surgery. During the study, participants will have quick LSCI scans lasting 5 to 10 seconds at different times around their revascularization procedure. These scans are safe and use low-intensity laser light that does not harm the skin. The study will track LSCI measurements alongside routine clinical assessments and foot temperature readings. The main goal is to measure how well LSCI can quantify blood flow changes in the legs, with follow-up lasting up to two years to correlate findings with clinical outcomes.
CONDITIONS
Brief Title
SPECTATOR: Perfusion Monitoring Before, During and After Lower Extremity Revascularization With Laser Speckle Contrast Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for lower-extremity revascularization
- Undergoing pre- and postoperative indocyanine near-infrared fluorescence perfusion measurements
- Adults aged 18 years or older
You will not qualify if you...
- Any condition that the investigator considers to be potentially jeopardizing the patient's wellbeing or the study objectives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Perioperative period
Participants undergo laser speckle contrast imaging (LSCI) measurements before, during, and after lower extremity revascularization to assess tissue perfusion.
1 preoperative visit, intraoperative measurement, and 1 postoperative visit
Duration - Up to 2 years
Participants are observed with follow-up assessments to correlate LSCI findings with clinical outcomes and foot temperature over time.
Follow-up visits during routine outpatient clinic appointments
Trial Site Locations
Total: 1 location
1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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