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Not yet recruitingNCT07347535Updated Jan 16, 2026

Non-invasive MSOT Examination of Muscle Oxygenation in Athletes and PAD Patients

An observational study in PAD - Peripheral Arterial Disease, sponsored by University Hospital Erlangen. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by University Hospital Erlangen · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • PAD - Peripheral Arterial Disease

Keywords

  • MSOT
  • PAD
  • Spiroergometry
03

In context

Peripheral Arterial Disease

1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.

This study's planned enrollment of 60 is below the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

University Hospital Erlangen is the lead sponsor of 28 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 may participate, as there are no risks of harm to the fetus.
  • Consent to pseudonymized data collection and storage in accordance with the GDPR.

Exclusion criteria

Exclusion Criteria:

  • 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 .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • PAD - peripheral artery disease

    Patients with PAD

    Diagnostic Test: MSOT - Multispectral optoacustic tomography · Diagnostic Test: CPET

  • Triathletes

    very fit subjects, who do triathlon

    Diagnostic Test: MSOT - Multispectral optoacustic tomography · Diagnostic Test: CPET

  • Strength athletes

    Strength athletes and bodybuilders

    Diagnostic Test: MSOT - Multispectral optoacustic tomography · Diagnostic Test: CPET

  • young, unathletic group

    Young, healthy and unathletic subjects between 18 - 40 years

    Diagnostic Test: MSOT - Multispectral optoacustic tomography · Diagnostic Test: CPET

  • older, unathletic group

    older, unathletic and healthy subjects between 55 - 75 years

    Diagnostic Test: MSOT - Multispectral optoacustic tomography · Diagnostic Test: CPET

  • training PAD Patients

    Diagnostic Test: MSOT - Multispectral optoacustic tomography · Diagnostic Test: CPET

Interventions

  • Diagnostic testMSOT - Multispectral optoacustic tomography

    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.

  • Diagnostic testCPET

    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.

06

What researchers measure

Primary outcomes

  1. Hemoglobin associated parameters measured via Multispectral optoacoustic Tomography

    using MSOT

    Time frame: through study completion, an average of 1 year

  2. 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.

    Time frame: through study completion, an average of 1 year

  3. 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).

    Time frame: Through study completion, average of 1 year

  4. Minute ventilation: Ventilation (L·min-¹)

    Minute ventilation measured during cardiopulmonary exercise testing (CPET).

    Time frame: Through study completion, average of 1 year

  5. Carbon dioxide production (VCO₂): VCO₂ (mL·min-¹)

    Carbon dioxide production measured during cardiopulmonary exercise testing (CPET).

    Time frame: Through study completion, average of 1 year

  6. Heart rate response to exercise: Heart rate (bpm)

    Heart rate measured at peak exercise during cardiopulmonary exercise testing (CPET).

    Time frame: Through study completion, average of 1 year

  7. Absolute oxygen consumption: VO₂ (mL·min-¹)

    Oxygen consumption measured during cardiopulmonary exercise testing (CPET).

    Time frame: Through study completion, average of 1 year

  8. 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).

    Time frame: Through study completion, average of 1 year

  9. 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.

    Time frame: Through study completion (an average of 1 year)

  10. 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.

    Time frame: Through study completion (an average of 1 year)

  11. 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.

    Time frame: Through study completion (an average of 1 year)

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2026; primary completion for Mar 2026, 2 months later.

Of 138 non-industry observational studies under Peripheral Arterial Disease, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's planned 2 months is below that.

Counting every sponsor, half of 196 studies reached it within 36 months; a quarter within 22 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2025
First posted
Jan 16, 2026
StartEst.
Jan 1, 2026
Primary completionEst.
Mar 1, 2026
CompletionEst.
Aug 1, 2026
Last update
Jan 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07347535
Lead sponsor
University Hospital Erlangen
Collaborators
PD Dr. med. Ferdinand Knieling, Department of pediatrics, University of Erlangen-Nürnberg
Responsible party
Ulrich Rother (Senior Consultant, Department of Vascular Surgery, University Hospital Erlangen, University Hospital Erlangen) — Principal investigator
First posted
Jan 16, 2026
Start date
Jan 1, 2026 (estimated)
Primary completion
Mar 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Jan 16, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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