An interventional study of MSOT in Peripheral Vascular Diseases, Peripheral Arterial Disease and Intermittent Claudication, sponsored by Ulrich Rother. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Ulrich Rother · Not applicable, Interventional, and Diagnostic
The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the gluteal muscle based on multispectral optoacoustic tomography (MSOT) in patients with gluteal claudication in Fontaine stage II (intermittent claudication) pre and post-intervention.
This is a monocentric, prospective study which aims to exanimate the optoacoustic signals in gluteal muscle after a exercise in patients with PAD in Fontaine stage II before and after the revascularisation to verify the change of MSOT by improved vascularization. MSOT data will be correlated with CCDS, ABI, treadmill test, subjectively perceived absolute walking distance in everyday life, PAD-related life quality (VASCUQOL-6) and TASC II classification in angiographic imaging (only in case angiographic imaging is available and independent from this study).
Patients with gluteal claudication in Fontaine stage II will be recruited during the consulting hours of the Department of Vascular Surgery, University Hospital Erlangen. Following detailed information about the study and after providing written consent, relevant clinical data will be collected from the electronical patient file, if available. In addition, a thorough anamnesis interview for relevant data and CCDS would be performed. Afterwards, the MSOT parameters will be recorded on gluteal muscles before and after a stepper exercise two minutes or until the occurrence of claudication pain in the gluteal muscle. The more affected side is examined. All data will be adequately pseudonymized in compliance with data protection regulations before they are used for statistical analysis. The duration of the study for participants will be max. 90 minutes. The angiographic imaging will be reviewed and analyzed.
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's planned enrollment of 20 is below the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →Ulrich Rother is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Compared within Intermittent Claudication, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peripheral Vascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus gluteus of the affected leg in PAD patients in Fontaine stage II (intermittent claudication) Physical assessment: Pulse status / Color-Coded Duplex Sonography / Ankle-Brachial Index / treadmill test / stepper exercise 2 minutes
Diagnostic Test: MSOT
Non-invasive transcutaneous imaging of muscle components via infrared and near-infrared laser pulses
Optimal diagnostic MSOT thresholds
optimal diagnostic threshold for hemoglobin-associated MSOT parameters in gluteal muscle tissue in patients with intermittent claudication before and after exercise
Time frame: twice (before and after the intervention, up to two weeks)
Improvement of the MSOT parameters after the revascularisation
Change of hemoglobin-associated MSOT parameters in gluteal muscle tissue in patients with intermittent claudication before and after exercise after the revascularisation
Time frame: twice (before and after the intervention, up to two weeks)
Difference between the corresponding MSOT values before and after exercis
Difference of the values before and after exercise for hemoglobin-associated parameters derived by transcutaneous MSOT in patients with gluteal claudication
Time frame: twice (before and after the intervention, up to two weeks)
Reperfusion profiles for hemoglobin-associated parameters
Curves of hemoglobin-associated MSOT parameters in the first ten minutes after exercise
Time frame: twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with the CCDS flow profile and PSV
Hemoglobin-associated MSOT parameters in patients with gluteal claudication correlated with the flow profile and PSV of A. femoralis communis and A. poplitea determined by CCDS
Time frame: single time point
Correlation of acquired MSOT parameters with the ABI
Hemoglobin-associated parameters derived by transcutaneous MSOT correlated with the ABI
Time frame: twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with threadmill test
Hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with Threadmill test
Time frame: twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with subjectively perceived maximum walking distance in everyday life
hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the subjectively perceived maximum walking distance in everyday life
Time frame: twice (before and after the intervention)
Correlation of acquired MSOT parameters with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire)
hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire)
Time frame: twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with the TASC-classification (angiography)
hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT in patients with PAD in Fontaine stage II correlated with the TASC-classification (angiography)
Time frame: twice (before and after the intervention, up to two weeks)
Confounder analysis
Correlation of all collected parameters (anamnestic, demographic, physiological) with regard to their characteristics as basic confounders for the MSOT technique
Time frame: twice (before and after the intervention, up to two weeks)
Plan to share: No
Ran from Jun 2023 to primary completion in Mar 2024, 8 months.
Of 73 non-industry interventional studies with no phase under Intermittent Claudication, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 77. This study's 8 months is below that.
Counting every sponsor, half of 84 studies reached it within 41 months; a quarter within 17 and three quarters within 77.
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