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

Last updated: April 28, 2024
Sponsor: Ulrich Rother
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Peripheral Arterial Occlusive Disease

Circulation Disorders

Treatment

MSOT

Clinical Study ID

NCT06391346
MSOT-gluteal
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Patients with PAD in Fontaine stage I, III and IV or Rutherford category 0, 4, 5 and 6or healthy volunteers with diabetes mellitus, chronic renal failure, claudicationsymptoms, 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 psychiatricconditions which, by the judgement of the study physician, would compromise theperson's safety or the quality of the data, thereby rendering the person an ineligiblecandidate for the study

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: MSOT
Phase:
Study Start date:
June 23, 2023
Estimated Completion Date:
April 30, 2024

Study 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.

Connect with a study center

  • University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery

    Erlangen, Bavaria 91054
    Germany

    Active - Recruiting

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