Photoacoustic Imaging to Assess Blood Vessels and Oxygen Levels in Feet of Adults With Lower Extremity Artery Disease or Healthy Volunteers

What this Trial Is About

Lower extremity artery disease LEAD is often underdiagnosed and untreated, leading to serious disability and death. Researchers are studying a new imaging method called photoacoustic tomography PACT to better evaluate the blood vessels and oxygen levels in the feet of people with LEAD. This technology can create detailed three-dimensional images without using contrast agents, potentially offering more complete information than current tests. Participants in this observational study will include both LEAD patients and healthy volunteers. They will undergo PACT imaging of their feet, which uses special ultrasound and photoacoustic techniques to capture high-resolution images of blood vessels and measure blood oxygen saturation and hemoglobin concentration. The study aims to assess how well this imaging method works and whether it adds value compared to existing diagnostic tools. During the study, participants will have their foot vasculature examined using the PACT system. Researchers will measure vessel density, oxygen saturation, and hemoglobin levels at baseline. The study involves no treatment and focuses on gathering detailed imaging data. Participants will be monitored for safety, and the study will run until the end of 2028, with involvement lasting as needed for imaging and assessments.

Photoacoustic Tomography in Assessment of Lower Extremity Artery Disease