ClinicalTrials.gg
Not yet recruitingNCT06645353Updated Oct 18, 2024

Evaluation of Perfusion and Oxygenation in Muscle of Patients With PAD Undergoing LER

An observational study in Peripheral Arterial Disease, sponsored by Medical University of Graz. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-18.

Sponsored by Medical University of Graz · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
55
Ages
18 Years and older
Sex
All
01

Study summary

During this IIT, the MSOT (Multispectral Optoacoustic Tomography ) Acuity Echo will be used to scan participants with Peripheral Arterial Disease assess MSOT Multispectral Optoacoustic Tomography (single-wavelength and hemoglobin-related parameters) in the Tibialis Anterior, and flexor hallucis brevis, at multiple time-points before, during and after interventional Lower Extremity Revascularization (LER ).

Primary aim of the study ist the Comparison of the difference between oxygenated, deoxygenated hemoglobin and oxygenation in the tibialis anterior, and flexor hallucis brevis, at multiple time-points before, during and after interventional Lower Extremity Revascularization.

02

Conditions studied

  • Peripheral Arterial Disease
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In context

Peripheral Arterial Disease

1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.

This study's planned enrollment of 55 is below the median of 190 across 427 observational studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 470 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

  • Participants with PAD stage 4 - 6 (Rutherford) with indication for interventional LER

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Written consent of the participant after being informed

      • Adults above 18 years
      • Participants with PAD stage 4 - 6 (Rutherford) with indication for interventional LER

Exclusion criteria

Exclusion Criteria:

    • Participants with previous LER on the same leg

      • Participants less than 18years
      • Pregnancy
      • Participants with tattoos in the scan area
      • Participants with no clinical indication for interventional LER
      • Missing consent form
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
55 participants (estimated)
Patient registry
No

Interventions

  • DeviceMSOT Multispectral Optoacoustic Tomography

    MSOT Multispectral Optoacoustic Tomography, single-wavelength, HbT, Hb, HbO2, collagen and mSO2 (700-1.100 nm wavelength range, in 10 nm increments) in the tibialis anterior and flexor hallucis brevis, at multiple time-points before, during and after interventional LER Lower Extremity Revascularization .

06

What researchers measure

Primary outcomes

  1. MSOT Multispectral Optoacoustic Tomography,

    single-wavelength, HbT, Hb, HbO2, collagen and mSO2 (700-1.100 nm wavelength range, in 10 nm increments) in the tibialis anterior and flexor hallucis brevis, at multiple time-points before, during and after interventional LER Lower Extremity Revascularization .

    Time frame: baseline pre LER, 30 minutes post LER, 24 hours post LER, 48hours post LER

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2024; primary completion for Jul 2025, 8 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2024
First posted
Oct 16, 2024
StartEst.
Nov 2024
Primary completionEst.
Jul 2025
CompletionEst.
Jul 2025
Last update
Oct 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06645353
Collaborators
iThera Medical GmbH
Responsible party
Sponsor
First posted
Oct 16, 2024
Start date
Nov 2024 (estimated)
Primary completion
Jul 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Oct 18, 2024

Study contacts

Astrid Friedel
Contact
astrid.friedel@medunigraz.at
031638578017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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