Actively Recruiting

Age: 18Years +
All Genders
ID07558174

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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