NCT05935839

Tissue Changes in Diabetes in Adults and Children Using Multispectral Optoacoustic Tomography.

Noninvasive Characterization of Tissue Changes in Diabetes in Adults and Children Using Multispectral Optoacoustic Tomography.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 6 Years – 99 Years
• Healthy volunteers: Accepted

Summary

In this study, blood flow and tissue changes in adult and pediatric patients with diabetes mellitus will be characterized by MSOT and compared with existing methods (ABI testing, neurological testing) (method comparison). The aim is to quantify changes and to possibly allow early detection of concomitant diseases. This could, similar to peripheral arterial occlusive disease, lead to a new possibility of non-invasive assessment of disease progression in the future.

Detailed description

After informing the patients and parents/guardians and checking the inclusion and exclusion criteria, the clinical data of the ill subjects are recorded and the HbA1c is measured in the laboratory as part of the routine recording. The blood collection is part of the routine diagnostics on presentation in the outpatient clinic and is performed separately from the study. Subsequently, imaging by MSOT is performed in all study participants. This is performed on both sides of the lower leg over the triceps surae muscle. The examination is analogous to sonography over the corresponding skin layers without further invasive procedures. The anatomical region can be localized by means of built-in sonography; subsequently, the corresponding optoacoustic signals can be derived over it. This is followed by measurement of the Arm-Brachial-Index. After a short recovery time, the test persons perform a physical stress on the examined lower leg muscles. After renewed ABI measurement, the imaging examination is repeated using MSOT. Finally, the neurological status is assessed using the Neuropathy Disability Score (NSS).

Conditions

• Diabetes Mellitus, Type 1
• Macroangiopathy

Interventions

Type	Name	Description
DEVICE	Multispectral optoacoustic tomography	Molecular Imaging of tissue changes using MSOT in macroangiopathy in diabetes. Dual imaging before and after physical stress.
DIAGNOSTIC_TEST	Ankle Brachial Index	Dual measurement of ABI index before and after physical exercise.
DIAGNOSTIC_TEST	Neuropathy Disability Score	Single measurement of the NSS

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2023-07-07
• Last updated: 2023-07-07