Investigation of the Perfusion of Gluteal Muscle in Patients With Intermittent Gluteal Claudication by Non-invasive MSOT
NCT ID: NCT06391346
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-06-23
2024-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patient
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
MSOT
Non-invasive transcutaneous imaging of muscle components via infrared and near-infrared laser pulses
Interventions
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MSOT
Non-invasive transcutaneous imaging of muscle components via infrared and near-infrared laser pulses
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ulrich Rother
OTHER
Responsible Party
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Ulrich Rother
PD Dr. med.
Locations
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University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery
Erlangen, Bavaria, Germany
Countries
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Facility Contacts
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References
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Lawall H, Diehm C, Hoffmann U, Reinecke H. [Update PAVK: Epidemiology, comorbidity and prognosis of peripheral arterial obstructive disease]. Dtsch Med Wochenschr. 2015 Dec;140(24):1798-802. doi: 10.1055/s-0041-107064. Epub 2015 Dec 1. German.
Alpert JS, Larsen OA, Lassen NA. Exercise and intermittent claudication. Blood flow in the calf muscle during walking studied by the xenon-133 clearance method. Circulation. 1969 Mar;39(3):353-9. doi: 10.1161/01.cir.39.3.353. No abstract available.
Karlas A, Masthoff M, Kallmayer M, Helfen A, Bariotakis M, Fasoula NA, Schafers M, Seidensticker M, Eckstein HH, Ntziachristos V, Wildgruber M. Multispectral optoacoustic tomography of peripheral arterial disease based on muscle hemoglobin gradients-a pilot clinical study. Ann Transl Med. 2021 Jan;9(1):36. doi: 10.21037/atm-20-3321.
Larsen ASF, Reiersen AT, Jacobsen MB, Klow NE, Nordanstig J, Morgan M, Wesche J. Validation of the Vascular quality of life questionnaire - 6 for clinical use in patients with lower limb peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 22;15(1):184. doi: 10.1186/s12955-017-0760-3.
Abraham P, Picquet J, Vielle B, Sigaudo-Roussel D, Paisant-Thouveny F, Enon B, Saumet JL. Transcutaneous oxygen pressure measurements on the buttocks during exercise to detect proximal arterial ischemia: comparison with arteriography. Circulation. 2003 Apr 15;107(14):1896-900. doi: 10.1161/01.CIR.0000060500.60646.E0. Epub 2003 Mar 31.
Assi H, Cao R, Castelino M, Cox B, Gilbert FJ, Grohl J, Gurusamy K, Hacker L, Ivory AM, Joseph J, Knieling F, Leahy MJ, Lilaj L, Manohar S, Meglinski I, Moran C, Murray A, Oraevsky AA, Pagel MD, Pramanik M, Raymond J, Singh MKA, Vogt WC, Wang L, Yang S, Members Of Ipasc, Bohndiek SE. A review of a strategic roadmapping exercise to advance clinical translation of photoacoustic imaging: From current barriers to future adoption. Photoacoustics. 2023 Aug 2;32:100539. doi: 10.1016/j.pacs.2023.100539. eCollection 2023 Aug.
Audonnet M, Signolet I, Colas-Ribas C, Ammi M, Abraham P, Henni S. Exercise Transcutaneous Oximetry of the Buttocks - External Validation With Computed Tomography Angiography. Circ J. 2017 Jul 25;81(8):1123-1128. doi: 10.1253/circj.CJ-16-1316. Epub 2017 Apr 13.
Batt M, Baque J, Bouillanne PJ, Hassen-Khodja R, Haudebourg P, Thevenin B. Percutaneous angioplasty of the superior gluteal artery for buttock claudication: a report of seven cases and literature review. J Vasc Surg. 2006 May;43(5):987-91. doi: 10.1016/j.jvs.2006.01.024.
Gernigon M, Marchand J, Ouedraogo N, Leftheriotis G, Piquet JM, Abraham P. Proximal ischemia is a frequent cause of exercise-induced pain in patients with a normal ankle to brachial index at rest. Pain Physician. 2013 Jan;16(1):57-64.
Other Identifiers
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MSOT-gluteal
Identifier Type: -
Identifier Source: org_study_id
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