Non-invasive imaging of perfusion and oxygenation of the LOWer extremities in healthy volunteers by means of Multispectral Optoacoustic Tomography (LOW-MSOT)

Non-invasive imaging of perfusion and oxygenation of the LOWer extremities in healthy volunteers by means of Multispectral Optoacoustic Tomography (LOW-MSOT) - LOW-MSOT imaging in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38860

Enrollment

Registered

2013-10-18

Start date

2014-01-03

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

perfusion and oxygenation of the lower legs

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy volunteers. - No prior or current medication. - Age >= 18 years. - Written informed consent. - Adequate potential for telephone follow-up 14 days following the measurement with MSOT.

Exclusion criteria

Exclusion criteria: - Medical or psychiatric conditions that compromise the volunteers' ability to give informed consent. - Concurrent uncontrolled medical conditions. - Any investigational treatment for peripheral vascular disease or lower leg fractures within the past month. - Pregnancy or breast feeding. - Clinically significant (i.e. active) cardiovascular disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication, peripheral vascular disease) or myocardial infarction within the past 12 months. - Patients with symptoms or history of peripheral neuropathy. - (Partial) amputation of one of the legs.

Design outcomes

Primary

Measure	Time frame
Determination of the measurement variation (mean and SD) of MSOT in physiological conditions of the lower leg. correlation of MSOT oxygenation and perfusion measurements with pulse oximetry of the hallux.	—

Secondary

Measure	Time frame
To obtain information on safety aspects of the MSOT imaging device, side effects, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR).	—

Countries

Netherlands

Outcome results