Trials / Recruiting
RecruitingNCT06391346
Investigation of the Perfusion of Gluteal Muscle in Patients With Intermittent Gluteal Claudication by Non-invasive MSOT
Evaluation of Gluteal Muscle Perfusion in Patients With Intermittent Gluteal Claudication by Non-invasive Multispectral Optoacoustic Tomography With Pre-post Study Design
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Ulrich Rother · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Peripheral Vascular Diseases
- Peripheral Arterial Disease
- Intermittent Claudication
- Gluteal Claudication
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | MSOT | Non-invasive transcutaneous imaging of muscle components via infrared and near-infrared laser pulses |
Timeline
- Start date
- 2023-06-23
- Primary completion
- 2024-03-14
- Completion
- 2024-04-01
- First posted
- 2024-04-30
- Last updated
- 2024-04-30
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT06391346. Inclusion in this directory is not an endorsement.