Vascular Disease，PeripheralSPECTATORNCT07558174
SPECTATOR: Perfusion Monitoring Before, During and After Lower Extremity Revascularization With Laser Speckle Contrast Imaging
An observational study of Vascular Disease，Peripheral, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
This study aims to evaluate the feasibility of Laser Speckle Contrast Imaging for perioperative perfusion assessment of the lower extremity before, during, and after revascularization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Disease，Peripheral
- What is being tested?
- Laser Speckle Contrast Imaging
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of this study will undergo a revascularization of the lower extremity due to peripheral artery disease. Such revascularization can be bypass surgery, thrombo-endarterectomy (TEA), or endovascular percutaneous transluminal angioplasty (PTA).
Who may be able to join
- Scheduled for lower-extremity revascularization
- Undergoing pre- and postoperative indocyanine near-infrared fluorescence perfusion measurements
Who cannot join
- Any condition that the investigator considers to be potentially jeopardizing the patient's wellbeing or the study objectives
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333ZA
Indy Planting, MD, +31614524783, i.planting@lumc.nl
Joost van der Vorst, PhD, J.R.van_der_Vorst@lumc.nl
About this study
This study aims to evaluate the feasibility of Laser Speckle Contrast Imaging for perioperative perfusion assessment of the lower extremity before, during, and after revascularization.
Read the detailed description
Rationale: Lower extremity arterial disease (LEAD) arises from atherosclerotic obstruction in the lower limbs, which in turn leads to symptoms ranging from intermittent claudication to ulcer formation. As the disease progresses, patients often require revascularization to achieve limb salvage.
To improve prediction of clinical outcomes following revascularization, various techniques have been introduced to quantify tissue perfusion. Among these, near-infrared fluorescence imaging with indocyanine green (ICG NIRF) has gained attention. This method combines a laser light source with intravenous ICG administration to visualize perfusion. Although ICG NIRF appears promising for guiding revascularization strategies and predicting outcomes, its invasive nature, requiring dye injection, limits its use in outpatient settings.
Consequently, there is a need for a non-invasive, real-time technique that enables rapid and straightforward perfusion assessment. One such promising approach is laser speckle contrast imaging (LSCI). Therefore, this study aims to evaluate the feasibility of LSCI for perioperative perfusion assessment of the lower extremity before, during, and after revascularization.
Objective:The primary objective of this study is to evaluate the feasibility of laser speckle contrast imaging (LSCI) for monitoring perfusion in the lower extremities during and following revascularization.
Secondary objectives include correlating LSCI findings with the temperature of the patient's foot, comparing LSCI with near-infrared fluorescence imaging using indocyanine green (ICG NIRF) and exploring potential quantitative approaches such as the assessment of blood flow pulsatility.
Study design: This study will be a prospective cohort study. Study population: Adult patients undergoing a revascularization of the lower extremity due to peripheral artery disease. Such revascularization can be bypass surgery, thrombo-endarterectomy (TEA), or endovascular percutaneous transluminal angioplasty (PTA).
Intervention: Patients will undergo peri-operative and post-operative LSCI.
Main study parameters/endpoints: The main study parameters are the quantified perfusion parameters measured with LSCI.
Nature and extent of the burden and risks associated with participation. The use of the LSCI device is not expected to cause any adverse effects, as it employs a low-intensity near-infrared laser to illuminate the skin. The photon energy and illumination power used are well below levels that could cause tissue damage and are therefore considered safe for human skin. All measurements are performed alongside standard assessments or routine outpatient clinic appointments. The intraoperative measurement does not extend the duration of the surgical procedure. Given the short duration of each measurement (5-10 seconds), no additional burden on patients is anticipated.
- Conditions
- Vascular Disease，Peripheral
- Being tested
- Laser Speckle Contrast Imaging
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Speckle Contrast ImagingDiagnostic test
Measurement with LSCI device
| Study group | Role | What they receive |
|---|---|---|
| Fontaine 2 | Not described Receives: Diagnostic Test: Laser Speckle Contrast Imaging | |
| Fontaine 3 | Not described Receives: Diagnostic Test: Laser Speckle Contrast Imaging | |
| Fontaine 4 | Not described Receives: Diagnostic Test: Laser Speckle Contrast Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility and the quantification of laser speckle contrast imaging for monitoring of perfusion of the lower extremities during and following revascularization
Feasibility
Measured: Up to 48 hours (from pre-operative baseline measurement to the final postoperative measurement, performed on the same day for PTA procedures or on postoperative day 1 for bypass and TEA procedures)
Secondary outcomes (5)
Correlation of pre-, intra- and postsurgery laser speckle contrast imaging (LSCI) findings with the pre-, intra- and post-temperature of the patient's foot
Temperature
Measured: Up to 48 hours (from pre-operative baseline measurement to the final postoperative measurement, performed on the same day for PTA procedures or on postoperative day 1 for bypass and TEA procedures)
Comparative analysis of LSCI with standard of care near-infrared fluorescence imaging using ICG
ICG
Measured: Up to 48 hours (from pre-operative baseline measurement to the final postoperative measurement, performed on the same day for PTA procedures or on postoperative day 1 for bypass and TEA procedures)
Clinical outcomes
Correlation of quantified LSCI recordings to clinical outcomes
Measured: Clinical outcome data (wound healing, limb salvage, complications) extracted from routine postoperative follow-up assessments, up to 6 weeks after revascularization; no additional study-specific measurements are performed at this follow-up visit
Effect of anesthesia induction on quantified LSCI perfusion values
Exploratory comparison of quantified laser speckle perfusion units (LSPU) in the plantar region of interest measured before versus within 15 minutes after induction of anesthesia (prior to revascularization), to assess whether anesthesia induction is associated with a change in LSCI-derived perfusion values. Measurement setup and non-invasive LSCI acquisition procedure are unchanged from the pre-anesthesia measurement; no additional burden or risk to participants.
Measured: Pre-anesthesia induction and within 15 minutes post-anesthesia induction
Exploratory assessment of blood flow pulsatility using LSCI
Exploratory, opportunistic analysis performed only in the subset of participants for whom intraoperative INVOS regional oximetry data are available as part of standard care; not assessed in all participants
Measured: Intraoperative, during the reperfusion phase (in the subset of participants undergoing TEA or PTA procedures with intraoperative regional oximetry monitoring)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Disease，PeripheralStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joost R. van der Vorst, MD, PhD, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558174
- Sponsor's protocol ID
- SPECTLSCI
- Acronym
- SPECTATOR
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECTATOR: Perfusion Monitoring Before, During and After Lower Extremity Revascularization With Laser Speckle Contrast Imaging
- ClinicalTrials.gov ID
- NCT07558174
- Acronym / sponsor ID
- SPECTATOR / SPECTLSCI
- Conditions
- Vascular Disease，Peripheral
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the feasibility of Laser Speckle Contrast Imaging for perioperative perfusion assessment of the lower extremity before, during, and after revascularization.
Detailed description
Rationale: Lower extremity arterial disease (LEAD) arises from atherosclerotic obstruction in the lower limbs, which in turn leads to symptoms ranging from intermittent claudication to ulcer formation. As the disease progresses, patients often require revascularization to achieve limb salvage.
To improve prediction of clinical outcomes following revascularization, various techniques have been introduced to quantify tissue perfusion. Among these, near-infrared fluorescence imaging with indocyanine green (ICG NIRF) has gained attention. This method combines a laser light source with intravenous ICG administration to visualize perfusion. Although ICG NIRF appears promising for guiding revascularization strategies and predicting outcomes, its invasive nature, requiring dye injection, limits its use in outpatient settings.
Consequently, there is a need for a non-invasive, real-time technique that enables rapid and straightforward perfusion assessment. One such promising approach is laser speckle contrast imaging (LSCI). Therefore, this study aims to evaluate the feasibility of LSCI for perioperative perfusion assessment of the lower extremity before, during, and after revascularization.
Objective:The primary objective of this study is to evaluate the feasibility of laser speckle contrast imaging (LSCI) for monitoring perfusion in the lower extremities during and following revascularization.
Secondary objectives include correlating LSCI findings with the temperature of the patient's foot, comparing LSCI with near-infrared fluorescence imaging using indocyanine green (ICG NIRF) and exploring potential quantitative approaches such as the assessment of blood flow pulsatility.
Study design: This study will be a prospective cohort study. Study population: Adult patients undergoing a revascularization of the lower extremity due to peripheral artery disease. Such revascularization can be bypass surgery, thrombo-endarterectomy (TEA), or endovascular percutaneous transluminal angioplasty (PTA).
Intervention: Patients will undergo peri-operative and post-operative LSCI.
Main study parameters/endpoints: The main study parameters are the quantified perfusion parameters measured with LSCI.
Nature and extent of the burden and risks associated with participation. The use of the LSCI device is not expected to cause any adverse effects, as it employs a low-intensity near-infrared laser to illuminate the skin. The photon energy and illumination power used are well below levels that could cause tissue damage and are therefore considered safe for human skin. All measurements are performed alongside standard assessments or routine outpatient clinic appointments. The intraoperative measurement does not extend the duration of the surgical procedure. Given the short duration of each measurement (5-10 seconds), no additional burden on patients is anticipated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fontaine 2 | – | Diagnostic Test: Laser Speckle Contrast Imaging |
| Fontaine 3 | – | Diagnostic Test: Laser Speckle Contrast Imaging |
| Fontaine 4 | – | Diagnostic Test: Laser Speckle Contrast Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this study will undergo a revascularization of the lower extremity due to peripheral artery disease. Such revascularization can be bypass surgery, thrombo-endarterectomy (TEA), or endovascular percutaneous transluminal angioplasty (PTA).
Key inclusion criteria (2 listed)
- Scheduled for lower-extremity revascularization
- Undergoing pre- and postoperative indocyanine near-infrared fluorescence perfusion measurements
Key exclusion criteria (1 listed)
- Any condition that the investigator considers to be potentially jeopardizing the patient's wellbeing or the study objectives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Speckle Contrast ImagingMeasurement with LSCI device | Diagnostic test | Fontaine 2, Fontaine 3, Fontaine 4 |
Primary outcome
To assess the feasibility and the quantification of laser speckle contrast imaging for monitoring of perfusion of the lower extremities during and following revascularization
Time frame: Up to 48 hours (from pre-operative baseline measurement to the final postoperative measurement, performed on the same day for PTA procedures or on postoperative day 1 for bypass and TEA procedures)
Feasibility
5 secondary outcomes
Correlation of pre-, intra- and postsurgery laser speckle contrast imaging (LSCI) findings with the pre-, intra- and post-temperature of the patient's foot
Time frame: Up to 48 hours (from pre-operative baseline measurement to the final postoperative measurement, performed on the same day for PTA procedures or on postoperative day 1 for bypass and TEA procedures)
Comparative analysis of LSCI with standard of care near-infrared fluorescence imaging using ICG
Time frame: Up to 48 hours (from pre-operative baseline measurement to the final postoperative measurement, performed on the same day for PTA procedures or on postoperative day 1 for bypass and TEA procedures)
Clinical outcomes
Time frame: Clinical outcome data (wound healing, limb salvage, complications) extracted from routine postoperative follow-up assessments, up to 6 weeks after revascularization; no additional study-specific measurements are performed at this follow-up visit
Effect of anesthesia induction on quantified LSCI perfusion values
Time frame: Pre-anesthesia induction and within 15 minutes post-anesthesia induction
Exploratory assessment of blood flow pulsatility using LSCI
Time frame: Intraoperative, during the reperfusion phase (in the subset of participants undergoing TEA or PTA procedures with intraoperative regional oximetry monitoring)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Disease，Peripheral, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility and the quantification of laser speckle contrast imaging for monitoring of perfusion of the lower extremities during and following revascularization (time frame: Up to 48 hours (from pre-operative baseline measurement to the final postoperative measurement, performed on the same day for PTA procedures or on postoperative day 1 for bypass and TEA procedures)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.