The evaluation of Personal Shear Rate Therapy on the hemodynamic and molecular effect in patients with peripheral artery disease

Personal Shear Rate Therapy on the hemodynamic and molecular effect in patients with peripheral artery disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19661956

Enrollment

Registered

2014-05-14

Start date

2014-03-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

PSRT effects on Peripheral arterial disease (PAD) Circulatory System Peripheral arterial disease (PAD)

Interventions

Thirteen patients with peripheral artery disease will be enrolled in a pre-test and post-test controlled trial and undergo 30 hours of personal shear rate therapy (PSRT) over 5 weeks and a control per

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 50 to 85 years 2. Fontaine classification for PAD II 3. Stable claudication over the last 5 weeks 4. Femoral-popliteal occlusion with one perfused calf artery 5. Willing to be assigned to any of the study intervention arms

Exclusion criteria

Exclusion criteria: 1. Smoking 2. Arrhythmia 3. Spastic palsy 4. Aortic valve insufficiency >II° 5. Acute deep vein thrombosis at the lower extremity 6. Dementia or severe cognitive disorder/mental retardation 7. Participation in another clinical trial

Design outcomes

Primary

Measure	Time frame
Change of endothelial function measured with flow-mediated dilation (FMD) and nitro-mediated dilation (NMD) using a high-definition ultrasound-system (HD11XE Philips) in the brachial artery, measured directly before and after PSRT as well in a control phase 5 weeks prior to treatment start	—

Secondary

Measure	Time frame
1. The relative Pulse Slope Index (rPSI) measured by ultrasound 2. The FMD of the common femoral artery measured by ultrasound 3. The Initial Claudication Distance (ICD) measured by the treadmill test with 3.5 km/h and 12% elevation 4. The Absolute Claudication Distance (ACD) measured by the treadmill test with 3.5 km/h and 12% elevation 5. Ankle-Brachial Index (ABI) 6. Quality of Life Questionnaire (Short-Form 36) 7. Electrical cardiometry ('Window to the heart' Osypka Medical GmbH) 8. Molecular parameters such as protein expression analysis (e.g., leukocyte telomerase activity), DNA expression analysis (e.g., leukocyte telomere length) , RNA expression analysis (e.g., iNOS), NO plasma levels, and plasma secretome analysis for endothelial monoculture, as well as endothelial cell and smooth muscle cell co-culture assays. Measured by qRT-PCR, western blot or ELISA, respectively Each outcome will be measured directly before and after PSRT as well in a control phase 5 weeks prior to treatment start. Likewise, for molecular analysis volunteer blood samples are collected at the beginning of 5 weeks of a control phase, before and after 45 minutes of ECP treatment and after 30 hours of ECP treatment.	—

Measure

Time frame

1. The relative Pulse Slope Index (rPSI) measured by ultrasound 2. The FMD of the common femoral artery measured by ultrasound 3. The Initial Claudication Distance (ICD) measured by the treadmill test with 3.5 km/h and 12% elevation 4. The Absolute Claudication Distance (ACD) measured by the treadmill test with 3.5 km/h and 12% elevation 5. Ankle-Brachial Index (ABI) 6. Quality of Life Questionnaire (Short-Form 36) 7. Electrical cardiometry ('Window to the heart' Osypka Medical GmbH) 8. Molecular parameters such as protein expression analysis (e.g., leukocyte telomerase activity), DNA expression analysis (e.g., leukocyte telomere length) , RNA expression analysis (e.g., iNOS), NO plasma levels, and plasma secretome analysis for endothelial monoculture, as well as endothelial cell and smooth muscle cell co-culture assays. Measured by qRT-PCR, western blot or ELISA, respectively Each outcome will be measured directly before and after PSRT as well in a control phase 5 weeks prior to treatment start. Likewise, for molecular analysis volunteer blood samples are collected at the beginning of 5 weeks of a control phase, before and after 45 minutes of ECP treatment and after 30 hours of ECP treatment.

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Countries

Germany

Outcome results

None listed

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