Investigation of the Perfusion of Gluteal Muscle in Patients With Intermittent Gluteal Claudication by Non-invasive MSOT

Ulrich Rother

Status: Enrolling

Conditions: Gluteal Claudication; Peripheral Vascular Diseases; Intermittent Claudication; Peripheral Arterial Disease

Treatments: Diagnostic Test: MSOT

Study type: Interventional

Funder types: Other

Identifiers

NCT06391346

MSOT-gluteal

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with gluteal claudication in Fontaine stage II and corresponding stenosis (common iliac artery, internal iliac artery or distal aorta)

Exclusion criteria

• Patients with PAD in Fontaine stage I, III and IV or Rutherford category 0, 4, 5 and 6 or healthy volunteers with diabetes mellitus, chronic renal failure, claudication symptoms, abnormal ABI or non-palpable foot pulses
• People with age under 18
• Absence of written consent
• Safety concerns of the study physician (person with physical, mental or psychiatric conditions which, by the judgement of the study physician, would compromise the person's safety or the quality of the data, thereby rendering the person an ineligible candidate for the study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Patient

Experimental group

Description:

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

Treatment:

Diagnostic Test: MSOT