Peripheral Arterial DiseaseNCT06645353
Evaluation of Perfusion and Oxygenation in Muscle of Patients With PAD Undergoing LER
An observational study of Peripheral Arterial Disease, run by Medical University of Graz.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- MSOT Multispectral Optoacoustic Tomography
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Jul 2025
- 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
- Adult, Older adult
Study population: • Participants with PAD stage 4 - 6 (Rutherford) with indication for interventional LER
Who may be able to join
- • Written consent of the participant after being informed
- Adults above 18 years
- Participants with PAD stage 4 - 6 (Rutherford) with indication for interventional LER
Who cannot join
- • 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- MSOT Multispectral Optoacoustic Tomography
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSOT Multispectral Optoacoustic TomographyDevice
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 .
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: baseline pre LER, 30 minutes post LER, 24 hours post LER, 48hours post LER
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Cross-sectional
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- iThera Medical GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645353
- Sponsor's protocol ID
- MSOT
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perfusion and Oxygenation in Muscle of Patients With PAD Undergoing LER
- ClinicalTrials.gov ID
- NCT06645353
- Acronym / sponsor ID
- MSOT
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- iThera Medical GmbH
- Study start
- Nov 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 16 Oct 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- • Participants with PAD stage 4 - 6 (Rutherford) with indication for interventional LER
Key inclusion criteria (3 listed)
- • Written consent of the participant after being informed
Key exclusion criteria (6 listed)
- • Participants with previous LER on the same leg
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 |
|---|---|---|
| MSOT Multispectral Optoacoustic TomographyMSOT 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 . | Device | – |
Primary outcome
MSOT Multispectral Optoacoustic Tomography,
Time frame: baseline pre LER, 30 minutes post LER, 24 hours post LER, 48hours post LER
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 .
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 18 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Medical University of Graz.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Astrid Friedel (031638578017, astrid.friedel@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSOT Multispectral Optoacoustic Tomography, (time frame: baseline pre LER, 30 minutes post LER, 24 hours post LER, 48hours post LER). 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 18 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.