RecruitingNot ApplicableNCT06391346

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


Sponsor

Ulrich Rother

Enrollment

20 participants

Start Date

Jun 23, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria4

  • 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

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Interventions

DIAGNOSTIC_TESTMSOT

Non-invasive transcutaneous imaging of muscle components via infrared and near-infrared laser pulses


Locations(1)

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

Erlangen, Bavaria, Germany

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NCT06391346


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