Pilot Study of Topographic Imaging of the Calf Muscle in Patients With PAD Using 3D Reconstructio… (NCT05110677) | Clinical Trial Compass
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Pilot Study of Topographic Imaging of the Calf Muscle in Patients With PAD Using 3D Reconstruction of MSOT Images
Germany9 participantsStarted 2021-11-24
Plain-language summary
The aim of this explorative pilot study is to present muscle perfusion of the lower extremity in patients with PAD using the Multispectral Optoacoustic Tomography (MSOT) method to build a 3D reconstruction of the calf muscle. This study aims to show the feasibility of 3D reconstruction of this non-invasive method. Advantages in diagnostics for patients with PAD and three-dimensional tomography representation of the perfusion situation based on muscle oxygenation will be evaluated.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with manifest PAD stages II-IV according to Fontaine or healthy volunteers
* Adult (\>18 years) persons who are able to give their consent
Exclusion Criteria:
* Patients with PAD stage I according to Fontaine
* Healthy volunteers with pre-existing diabetes mellitus, chronic renal failure, or abnormal ABI
* Underage persons
* Missing consent form
* Exclusion due to safety concerns of the study physician (patient with a physical, mental or psychiatric illness which, in the opinion of the study physician, would compromise the safety of the patient or the quality of the data and thus make the patient an unsuitable candidate for the study)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MSOT topogram showing MSOT parameters from 660 up to 1100 nm of the gastrocnemius muscle