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Study on Real-time Evaluation and Personalized Regulation Method of Lower Limb Blood Perfusion Improvement by External Counterpulsation Based on Multi-physiological Signal Analysis

Study on Real-time Evaluation and Personalized Regulation Method of Lower Limb Blood Perfusion Improvement by External Counterpulsation Based on Multi-physiological Signal Analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123065
Enrollment
Unknown
Registered
2026-04-21
Start date
2023-12-06
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Peripheral artery disease

Interventions

peripheral artery disease:Received a single forty-five-minute session of EECP
healthy subjects:Received a single forty-five-minute session of EECP

Sponsors

Qingdao Municipal Hospital (Qingdao Hospital of Rehabilitation University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with lower extremity peripheral artery disease (PAD):(1) Aged 45–75 years;(2) Patients from outpatient, inpatient, or community health settings with significant stenosis (moderate or above) of infrapopliteal vessels detected by ultrasound; (3) Ankle-brachial index (ABI) < 0.9; (4) Fontaine class I and IIa: [Class I: asymptomatic; Class II: IIa mild claudication, IIb moderate to severe claudication; Class III: ischemic rest pain;Class IV: tissue ulceration or gangrene]; (5) This study was approved by the Medical Ethics Committee, and written informed consent was voluntarily obtained from all patients or their legal representatives after full explanation of the study protocol. 2. Healthy Volunteers :(1) Aged 25–75 years; (2) Body mass index (BMI) 18.5–23.9, non-smoker and non-alcohol abuser; (3) Physical examination report confirms good health, with normal blood pressure, blood lipids, blood glucose, etc., no history of cardiovascular diseases or medication use; (4) Fully understand and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with lower extremity peripheral artery disease (PAD): (1) Patients with lower extremity amputation; (2) Walking dysfunction caused by non-lower extremity vascular stenosis; (3) Severe foot ulcer or severe limb ischemia; (4) Patients with lower extremity stents; (5) Contraindications to EECP, including: Moderate to severe aortic insufficiency; Dissecting aneurysm; Significant pulmonary hypertension; Various hemorrhagic diseases or bleeding tendency, or anticoagulant use with INR > 2.0; Various valvular heart diseases or congenital heart diseases accompanied by cardiac insufficiency; Active phlebitis and venous thrombosis; Severe left heart failure; Uncontrolled severe hypertension (> 170/110 mmHg); Uncontrolled arrhythmias, including frequent premature beats, while patients with atrial fibrillation may still benefit; Infection focus in the limbs to be counterpulsated; Severe lower extremity arterial occlusive disease; Pregnancy; (6) Patients with arterial thrombosis and unstable plaques; (7) Patients with severe dysfunction of the heart, liver, kidney, lung or other organs; (8) Patients with mental disorders or cognitive impairment; (9) Patients with incomplete general data or those who withdrew from the study midway. 2. Healthy Volunteers : (1) A history of cardiovascular and cerebrovascular diseases such as coronary heart disease and hypertension, or diagnosed metabolic diseases including diabetes and hyperlipidemia; (2) A long-term history of medication use, or administration of any drugs or foods affecting cardiovascular and cerebrovascular function within 7 days before the test; (3) Contraindications to external counterpulsation.

Design outcomes

Primary

MeasureTime frame
Ultrasound imaging data;Electrocardiogram(ECG) data;Dorsalis pedis pulse wave signal;Fingertip photoplethysmography (PPG);

Countries

China

Contacts

Public ContactZhang Yahui

Qingdao Municipal Hospital (Qingdao Hospital of Rehabilitation University)

zhangyahui@uhrs.edu.cn+86 135 1049 6787

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026