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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06645353
Enrollment
55
Registered
2024-10-16
Start date
2024-11-30
Completion date
2025-07-31
Last updated
2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Brief 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.

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 .

Sponsors

iThera Medical GmbH
CollaboratorINDUSTRY
Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

* • 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

Design outcomes

Primary

MeasureTime frameDescription
MSOT Multispectral Optoacoustic Tomography,baseline pre LER, 30 minutes post LER, 24 hours post LER, 48hours post LERsingle-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 .

Contacts

Primary ContactAstrid Friedel
astrid.friedel@medunigraz.at031638578017

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026