PAD - Peripheral Arterial DiseaseNCT07347535
Non-invasive MSOT Examination of Muscle Oxygenation in Athletes and PAD Patients
An observational study of PAD - Peripheral Arterial Disease, run by University Hospital Erlangen.
Trial summary
The aim of the study is to present the quantitative differences in oxygenated hemoglobin in different cohorts. This clinical study evaluates whether there is a correlation between measurements using multispectral optoacoustic tomography and the results of spiroergometry in the context of performance diagnostics. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- PAD - Peripheral Arterial Disease
- What is being tested?
- MSOT - Multispectral optoacustic tomography and CPET
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include adult participants aged 18 to 75 years, representing different levels of physical activity and vascular health status. A total of approximately 60 participants will be recruited, divided into six cohorts of about ten individuals each. Cohort Description: * Young endurance athletes (≥ 3 times per week, ≥ 60 minutes per session) Examples: running, cycling, swimming * Young strength athletes (≥ 3 times per week, ≥ 60 minutes) No additional endurance training * Young healthy controls Less than 2 times per week and < 30 minutes of physical activity No known vascular or muscular diseases * Patients with peripheral arterial disease (PAD) Diagnosed with PAD, Fontaine stage I, IIa or IIb * Older inactive controls Age above 55 years, no regular physical activity, no pAVK * Patients with PAD (Fontaine stage I, IIa or IIb, who participate in structured walking training
Who may be able to join
- Age ≥ 18 years (adults capable of giving consent)
- Capacity to consent. The subjects are able to understand the information provided and give their written consent.
- Belonging to one of the following cohorts:
- Endurance athletes: at least 3× per week ≥ 60 minutes of intensive endurance training (e.g., running, cycling, swimming)
- Strength athletes: at least 3× per week ≥ 60 minutes of intensive strength training without additional endurance training
- Healthy control subjects: less than 2× per week < 30 minutes of physical activity, no known vascular diseases
- PAD patients: diagnosed peripheral arterial occlusive disease in Fontaine stage I or IIa Women of childbearing age with or without contraception may participate, as there are no risks of harm to the fetus.
- Consent to pseudonymized data collection and storage in accordance with the GDPR.
Who cannot join
- Age over 75 years
- Minors (Age < 18)
- safety concerns on the part of the study physician, e.g., in the case of of: physical, mental or psychiatric illnesses, acute or chronic conditions that could jeopardise safety or data quality
- Taking medications that could affect physical performance or physiological measurements (e.g., heart rate, oxygen uptake).
- Pregnancy with known risks or complications (participation is possible in principle, but subject to individual medical review).
- Refusal to participate or lack of informed consent.
About this study
Official title: Non-invasive Assessment of Skeletal Muscle Oxygenation in Athletes and Patients With Peripheral Arterial Disease Using Multispectral Optoacoustic Tomography During Standardized Physical Exercise
The aim of the study is to present the quantitative differences in oxygenated hemoglobin in different cohorts.
This clinical study evaluates whether there is a correlation between measurements using multispectral optoacoustic tomography and the results of spiroergometry in the context of performance diagnostics.
Read the detailed description
This study aims to investigate the muscle metabolism of athletes (endurance and strength athletes), PAD patients, and healthy control subjects using non-invasive multispectral optoacoustic tomography as part of interval treadmill spiroergometry. The aim is to take a closer look at changes in oxygen supply and muscle metabolism in the various patient groups during the recovery phase. To this end, the individual groups will perform a performance diagnosis on a treadmill spiroergometer, adapted to their respective estimated physical performance (in the case of PAD patients, taking into account the possibilities given by the disease), which will be carried out in the form of a step test. In addition, MSOT measurements will be taken between the individual steps.
The aim of this study is to use MSOT to visualize and compare the muscle perfusion-in particular the proportion of oxygenated and deoxygenated hemoglobin (Hb)-of the various cohorts, as well as to compare it with the diagnostics and methods commonly used to date and identify any advantages. In the future, this could contribute to a better understanding of muscle perfusion, especially in connection with diseases such as PAD or other muscle lesions in sports medicine.
- Conditions
- PAD - Peripheral Arterial Disease
- Being tested
- MSOT - Multispectral optoacustic tomography, CPET
- Keywords
- MSOT, PAD, Spiroergometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSOT - Multispectral optoacustic tomographyDiagnostic test
MSOT is an advanced imaging technology that combines laser-induced ultrasound and light absorption to visualize biological tissues. By detecting ultrasound waves generated from tissue absorption of multispectral light, MSOT provides high-resolution, real-time images with functional and molecular information. One of its use is in biomedical research and clinical applications to study blood oxygenation and tissue composition, making it valuable for areas such as vascular research. In this study, we aim to utilize MSOT to differentiate between venous, arteriovenous and lymphatic malformations.
CPETDiagnostic test
Spiroergometry (also called cardiopulmonary exercise testing, CPET) is a diagnostic test that measures how the heart, lungs, and muscles work together during physical activity. While a person performs exercise treadmill the test records breathing gases (oxygen uptake and carbon dioxide output), ventilation, heart rate, and workload.
It provides valuable information about aerobic capacity, endurance, and limitations caused by cardiovascular, pulmonary, or metabolic conditions, making it useful in sports medicine, rehabilitation, and clinical diagnostics.
| Study group | Role | What they receive |
|---|---|---|
| PAD - peripheral artery disease | Patients with PAD Receives: Diagnostic Test: MSOT - Multispectral optoacustic tomography; Diagnostic Test: CPET | |
| Triathletes | very fit subjects, who do triathlon Receives: Diagnostic Test: MSOT - Multispectral optoacustic tomography; Diagnostic Test: CPET | |
| Strength athletes | Strength athletes and bodybuilders Receives: Diagnostic Test: MSOT - Multispectral optoacustic tomography; Diagnostic Test: CPET | |
| young, unathletic group | Young, healthy and unathletic subjects between 18 - 40 years Receives: Diagnostic Test: MSOT - Multispectral optoacustic tomography; Diagnostic Test: CPET | |
| older, unathletic group | older, unathletic and healthy subjects between 55 - 75 years Receives: Diagnostic Test: MSOT - Multispectral optoacustic tomography; Diagnostic Test: CPET | |
| training PAD Patients | Not described Receives: Diagnostic Test: MSOT - Multispectral optoacustic tomography; Diagnostic Test: CPET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin associated parameters measured via Multispectral optoacoustic Tomography
using MSOT
Measured: through study completion, an average of 1 year
Peak oxygen uptake (VO₂peak): VO₂peak (mL·kg-¹·min-¹)
Peak oxygen uptake measured during cardiopulmonary exercise testing (CPET), defined as the highest oxygen uptake achieved during maximal exercise.
Measured: through study completion, an average of 1 year
Respiratory exchange ratio (RER): RER (VCO₂/VO₂, unitless)
Respiratory exchange ratio measured during cardiopulmonary exercise testing (CPET) and calculated as the ratio of carbon dioxide production to oxygen consumption (VCO₂/VO₂).
Measured: Through study completion, average of 1 year
Minute ventilation: Ventilation (L·min-¹)
Minute ventilation measured during cardiopulmonary exercise testing (CPET).
Measured: Through study completion, average of 1 year
Carbon dioxide production (VCO₂): VCO₂ (mL·min-¹)
Carbon dioxide production measured during cardiopulmonary exercise testing (CPET).
Measured: Through study completion, average of 1 year
Heart rate response to exercise: Heart rate (bpm)
Heart rate measured at peak exercise during cardiopulmonary exercise testing (CPET).
Measured: Through study completion, average of 1 year
Absolute oxygen consumption: VO₂ (mL·min-¹)
Oxygen consumption measured during cardiopulmonary exercise testing (CPET).
Measured: Through study completion, average of 1 year
Anaerobic threshold: HR or workload at AT unit: bpm or km/h
Heart rate and workload at anaerobic threshold determined during cardiopulmonary exercise testing (CPET).
Measured: Through study completion, average of 1 year
Breathing reserve; Percentage (%)
using CPET Breathing reserve measured during cardiopulmonary exercise testing (CPET) and calculated as the percentage difference between maximal voluntary ventilation and peak exercise ventilation.
Measured: Through study completion (an average of 1 year)
Ventilatory equivalent for oxygen (VE/VO₂): Unitless
Ventilatory equivalent for oxygen measured during cardiopulmonary exercise testing (CPET) and defined as the ratio of minute ventilation to oxygen consumption.
Measured: Through study completion (an average of 1 year)
Ventilatory equivalent for carbon dioxide (VE/VCO₂): Unitless
Ventilatory equivalent for carbon dioxide measured during cardiopulmonary exercise testing (CPET) and defined as the ratio of minute ventilation to carbon dioxide production.
Measured: Through study completion (an average of 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAD - Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Erlangen-Nürnberg
- Responsible party
- Principal investigator, Ulrich Rother, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347535
- Sponsor's protocol ID
- MSOT_SPO2RT
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Assessment of Skeletal Muscle Oxygenation in Athletes and Patients With Peripheral Arterial Disease Using Multispectral Optoacoustic Tomography During Standardized Physical Exercise
- ClinicalTrials.gov ID
- NCT07347535
- Acronym / sponsor ID
- MSOT_SPO2RT
- Conditions
- PAD - Peripheral Arterial Disease
- Keywords
- MSOT, PAD, Spiroergometry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Collaborators
- University of Erlangen-Nürnberg
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to present the quantitative differences in oxygenated hemoglobin in different cohorts.
This clinical study evaluates whether there is a correlation between measurements using multispectral optoacoustic tomography and the results of spiroergometry in the context of performance diagnostics.
Detailed description
This study aims to investigate the muscle metabolism of athletes (endurance and strength athletes), PAD patients, and healthy control subjects using non-invasive multispectral optoacoustic tomography as part of interval treadmill spiroergometry. The aim is to take a closer look at changes in oxygen supply and muscle metabolism in the various patient groups during the recovery phase. To this end, the individual groups will perform a performance diagnosis on a treadmill spiroergometer, adapted to their respective estimated physical performance (in the case of PAD patients, taking into account the possibilities given by the disease), which will be carried out in the form of a step test. In addition, MSOT measurements will be taken between the individual steps.
The aim of this study is to use MSOT to visualize and compare the muscle perfusion-in particular the proportion of oxygenated and deoxygenated hemoglobin (Hb)-of the various cohorts, as well as to compare it with the diagnostics and methods commonly used to date and identify any advantages. In the future, this could contribute to a better understanding of muscle perfusion, especially in connection with diseases such as PAD or other muscle lesions in sports medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PAD - peripheral artery disease | – | Diagnostic Test: MSOT - Multispectral optoacustic tomography, Diagnostic Test: CPETPatients with PAD |
| Triathletes | – | Diagnostic Test: MSOT - Multispectral optoacustic tomography, Diagnostic Test: CPETvery fit subjects, who do triathlon |
| Strength athletes | – | Diagnostic Test: MSOT - Multispectral optoacustic tomography, Diagnostic Test: CPETStrength athletes and bodybuilders |
| young, unathletic group | – | Diagnostic Test: MSOT - Multispectral optoacustic tomography, Diagnostic Test: CPETYoung, healthy and unathletic subjects between 18 - 40 years |
| older, unathletic group | – | Diagnostic Test: MSOT - Multispectral optoacustic tomography, Diagnostic Test: CPETolder, unathletic and healthy subjects between 55 - 75 years |
| training PAD Patients | – | Diagnostic Test: MSOT - Multispectral optoacustic tomography, Diagnostic Test: CPET |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult participants aged 18 to 75 years, representing different levels of physical activity and vascular health status. A total of approximately 60 participants will be recruited, divided into six cohorts of about ten individuals each. Cohort Description: * Young endurance athletes (≥ 3 times per week, ≥ 60 minutes per session) Examples: running, cycling, swimming * Young strength athletes (≥ 3 times per week, ≥ 60 minutes) No additional endurance training * Young healthy controls Less than 2 times per week and < 30 minutes of physical activity No known vascular or muscular diseases * Patients with peripheral arterial disease (PAD) Diagnosed with PAD, Fontaine stage I, IIa or IIb * Older inactive controls Age above 55 years, no regular physical activity, no pAVK * Patients with PAD (Fontaine stage I, IIa or IIb, who participate in structured walking training
Key inclusion criteria (8 listed)
- Age ≥ 18 years (adults capable of giving consent)
- Capacity to consent. The subjects are able to understand the information provided and give their written consent.
- Belonging to one of the following cohorts:
- Endurance athletes: at least 3× per week ≥ 60 minutes of intensive endurance training (e.g., running, cycling, swimming)
- Strength athletes: at least 3× per week ≥ 60 minutes of intensive strength training without additional endurance training
Key exclusion criteria (6 listed)
- Age over 75 years
- Minors (Age < 18)
- safety concerns on the part of the study physician, e.g., in the case of of: physical, mental or psychiatric illnesses, acute or chronic conditions that could jeopardise safety or data quality
- Taking medications that could affect physical performance or physiological measurements (e.g., heart rate, oxygen uptake).
- Pregnancy with known risks or complications (participation is possible in principle, but subject to individual medical review).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSOT - Multispectral optoacustic tomographyMSOT is an advanced imaging technology that combines laser-induced ultrasound and light absorption to visualize biological tissues. By detecting ultrasound waves generated from tissue absorption of multispectral light, MSOT provides high-resolution, real-time images with functional and molecular information. One of its use is in biomedical research and clinical applications to study blood oxygenation and tissue composition, making it valuable for areas such as vascular research. In this study, we aim to utilize MSOT to differentiate between venous, arteriovenous and lymphatic malformations. | Diagnostic test | PAD - peripheral artery disease, Strength athletes, Triathletes, older, unathletic group, training PAD Patients, young, unathletic group |
| CPETSpiroergometry (also called cardiopulmonary exercise testing, CPET) is a diagnostic test that measures how the heart, lungs, and muscles work together during physical activity. While a person performs exercise treadmill the test records breathing gases (oxygen uptake and carbon dioxide output), ventilation, heart rate, and workload. It provides valuable information about aerobic capacity, endurance, and limitations caused by cardiovascular, pulmonary, or metabolic conditions, making it useful in sports medicine, rehabilitation, and clinical diagnostics. | Diagnostic test | PAD - peripheral artery disease, Strength athletes, Triathletes, older, unathletic group, training PAD Patients, young, unathletic group |
Primary outcome
Hemoglobin associated parameters measured via Multispectral optoacoustic Tomography
Time frame: through study completion, an average of 1 year
using MSOT
Peak oxygen uptake (VO₂peak): VO₂peak (mL·kg-¹·min-¹)
Time frame: through study completion, an average of 1 year
Peak oxygen uptake measured during cardiopulmonary exercise testing (CPET), defined as the highest oxygen uptake achieved during maximal exercise.
Respiratory exchange ratio (RER): RER (VCO₂/VO₂, unitless)
Time frame: Through study completion, average of 1 year
Respiratory exchange ratio measured during cardiopulmonary exercise testing (CPET) and calculated as the ratio of carbon dioxide production to oxygen consumption (VCO₂/VO₂).
Minute ventilation: Ventilation (L·min-¹)
Time frame: Through study completion, average of 1 year
Minute ventilation measured during cardiopulmonary exercise testing (CPET).
Carbon dioxide production (VCO₂): VCO₂ (mL·min-¹)
Time frame: Through study completion, average of 1 year
Carbon dioxide production measured during cardiopulmonary exercise testing (CPET).
Heart rate response to exercise: Heart rate (bpm)
Time frame: Through study completion, average of 1 year
Heart rate measured at peak exercise during cardiopulmonary exercise testing (CPET).
Absolute oxygen consumption: VO₂ (mL·min-¹)
Time frame: Through study completion, average of 1 year
Oxygen consumption measured during cardiopulmonary exercise testing (CPET).
Anaerobic threshold: HR or workload at AT unit: bpm or km/h
Time frame: Through study completion, average of 1 year
Heart rate and workload at anaerobic threshold determined during cardiopulmonary exercise testing (CPET).
Breathing reserve; Percentage (%)
Time frame: Through study completion (an average of 1 year)
using CPET Breathing reserve measured during cardiopulmonary exercise testing (CPET) and calculated as the percentage difference between maximal voluntary ventilation and peak exercise ventilation.
Ventilatory equivalent for oxygen (VE/VO₂): Unitless
Time frame: Through study completion (an average of 1 year)
Ventilatory equivalent for oxygen measured during cardiopulmonary exercise testing (CPET) and defined as the ratio of minute ventilation to oxygen consumption.
Ventilatory equivalent for carbon dioxide (VE/VCO₂): Unitless
Time frame: Through study completion (an average of 1 year)
Ventilatory equivalent for carbon dioxide measured during cardiopulmonary exercise testing (CPET) and defined as the ratio of minute ventilation to carbon dioxide production.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Related trials for PAD - Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of PAD - Peripheral Arterial Disease, run by University Hospital Erlangen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin associated parameters measured via Multispectral optoacoustic Tomography (time frame: through study completion, an average of 1 year). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.