Calf Muscle Perfusion in Patients With Intermittent Claudication by Non-invasive MSOT

NCT05373927 | Unknown

• 1 other identifier: MSOT_IC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the calf muscle based on multispectral optoacoustic tomography (MSOT) in a cross-sectional collective of patients with PAD in Fontaine stage II (intermittent claudication) and a healthy control collective (study group 1). The results will be validated using an independent validation group (study group 2).

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication

Keywords

Peripheral Vascular Diseases; Peripheral Arterial Disease; Peripheral Artery Disease; PAD; Intermittent Claudication; Claudicatio intermittens; Critical Limb Ischaemia; CLI; Critical Limb Threatening Ischemia; CTLI; Color-Coded Duplex Sonography; CCDS; Ankle Brachial Index; ABI; Multispectral Optoacoustic Tomography; MSOT; Heel Raises; 6-minute walk test; 6MWT; Muscle Perfusion; Calf Muscle Perfusion

Outcome Measures

Primary Outcomes (1)

• Optimal diagnostic MSOT thresholds

  Optimal diagnostic threshold for hemoglobin-associated MSOT parameters in calf muscle tissue in patients with intermittent claudication before and after exercise

  single time point (1 day)

Secondary Outcomes (15)

• Difference between the corresponding MSOT values before and after exercise

  single time point (1 day)

• Reperfusion profiles for hemoglobin-associated parameters

  single time point (1 day)

• Correlation of acquired MSOT parameters with the CCDS flow profile and PSV

  single time point (1 day)

• Correlation of acquired MSOT parameters with the ABI

  single time point (1 day)

• Correlation of acquired MSOT parameters with relative and absolute walking distance

  single time point (1 day)

Study Arms (2)

Study group 1

Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus triceps surae of the affected leg in PAD patients in Fontaine stage II (intermittent claudication) or one leg in healthy volunteers (total 1 site) Physical assessment: Pulse status / Color-Coded Duplex Sonography / Ankle-Brachial Index / 6-minute walk test (6MWT) / Continued heel raises for at least 30s

Device: Multispectral Optoacoustic Tomography (MSOT)

Study group 2

Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus triceps surae of the affected leg in PAD patients in Fontaine stage II (intermittent claudication) or one leg in healthy volunteers (total 1 site) Physical assessment: Pulse status / Color-Coded Duplex Sonography / Ankle-Brachial Index / 6-minute walk test (6MWT) / Continued heel raises for at least 30s

Device: Multispectral Optoacoustic Tomography (MSOT)

Interventions

Multispectral Optoacoustic Tomography (MSOT) DEVICE

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

Study group 1; Study group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with * PAD IIa * PAD IIb presenting for consultation during consultation hours of the department of vascular surgery. Healthy volunteers being recruited by notices posted in the clinic with following conditions: * no PAD previously known * no diabetes mellitus previously known * no chronic renal insufficiency previously known * no symptoms of intermittent claudication * ABI with values between 0.9 and 1.4 (screening examination before inclusion in the study) * palpable foot pulses

You may qualify if:

• Patients with manifest PAD in stage II according to Fontaine or categories 1-3 according to Rutherford or healthy volunteers
• Adults (\>18 years) who are able to give their consent

You may not qualify if:

• Patients with PAD stage I, III and IV according to Fontaine or categories 0, 4, 5 and 6 according to Rutherford or healthy volunteers with diabetes mellitus, chronic renal failure, claudication symptoms, abnormal ABI or non-palpable foot pulses
• Underage persons
• Lack 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)

Sponsors & Collaborators

• Ulrich Rother: lead
• PD Dr. med. Ferdinand Knieling, Department of pediatrics, University of Erlangen-Nürnberg: collaborator

Study Sites (1)

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

Erlangen, Bavaria, 91054, Germany

RECRUITING

Related Publications (5)

• 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.

  PMID: 26625226 BACKGROUND

• Lawall H, Huppert P, Espinola-Klein C, Zemmrich CS, Ruemenapf G. German guideline on the diagnosis and treatment of peripheral artery disease - a comprehensive update 2016. Vasa. 2017 Mar;46(2):79-86. doi: 10.1024/0301-1526/a000603. Epub 2017 Jan 27.

  PMID: 28128018 BACKGROUND

• 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.

  PMID: 4885945 BACKGROUND

• 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.

  PMID: 33553329 BACKGROUND

• 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.

  PMID: 28938901 BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes; Ischemia

Central Study Contacts

Ulrich Rother, PD Dr. med.

CONTACT

+4991318542028; ulrich.rother@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: June 20, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

DE (1)