Analysis of time-dependent changes in immune cell distribution and expression of immunological cytokines in patients with different stages of peripheral arterial disease (PAD)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032916

Enrollment

100

Registered

2023-10-25

Start date

2023-03-27

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

I70.2

Interventions

Group 1: Healthy subjects who do not have arteriosclerosis Group 2: Patients with peripheral arterial disease (PAD) (classification according to Fontaine) stage IIb Group 3: Patients with peripheral

Eligibility

Sex/Gender

All

Age

55 Years to No maximum

Inclusion criteria

Inclusion criteria: • Legally competent patients who have been informed about the study in writing and verbally and have agreed to participate. • Women and men over 18 years of age who have been diagnosed with PAD in Stage IIb, III or IV according to Fontaine using clinical examination, ABI measurement and, if necessary, appropriate imaging (duplex sonography, CTA; MRA). The examinations are carried out exclusively for the purpose of medical treatment. • Competent healthy women and men over 18 years of age who agreed to participate in this study as a healthy control group. The assignment as a control group is based on the lack of symptoms. No clinical examinations are carried out to rule out an illness.

Exclusion criteria

Exclusion criteria: • Patients with tumor diagnosis • Bedridden patients, as these patients may suffer from inflammatory processes (e.g. as a result of dekubitus). • Patients with sepsis criteria or accompanying infection such as urinary tract infection, pneumonia, cellulitis, open wound with signs of infection, etc. • Immunosuppression or taking immunosuppressive medications • Patients whose health conditions do not permit blood sampling • Incompetent patients or subjects • Overweight subjects with high BMI of 35 or greater

Design outcomes

Primary

Measure	Time frame
• Identification of changes in the amount of monocyte classes, Th-cells and regulatory T cells in the blood of patients with PAD of various stages over a year. • Identification of changes in the concentration of cytokines specific to monocytes, Th-cells and regulatory T cells. • Determination of serum-dependent in vitro differentiation of monocytes into classical M1 or non-classical M2 macrophages.	—

Measure

Time frame

• Identification of changes in the amount of monocyte classes, Th-cells and regulatory T cells in the blood of patients with PAD of various stages over a year. • Identification of changes in the concentration of cytokines specific to monocytes, Th-cells and regulatory T cells. • Determination of serum-dependent in vitro differentiation of monocytes into classical M1 or non-classical M2 macrophages.

—

Secondary

Measure	Time frame
Identification of key events by correlating identified changes with disease progression in patients with PAD.	—

Countries

Germany

Contacts

Public ContactDaniele De Donato

Universitätsklinikum Augsburg

Daniele.DeDonato2@uk-augsburg.de0049 821 400 168976

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026