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Therapeutic Efficacy of Enhanced External CounterPulsation in Patients with Intermittent Claudication: A Single center, prospective, randomized, controlled Trial

Therapeutic Efficacy of Enhanced External CounterPulsation in Patients with Intermittent Claudication: A Single center, prospective, randomized, controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118481
Enrollment
Unknown
Registered
2026-02-06
Start date
2026-02-28
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Lower Extremity Arteriosclerosis Obliterans

Interventions

EECP group:EECP treatment

Sponsors

The Eighth Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 40 years; 2.No restrictions based on sex. 3.Diagnosis of atherosclerosis obliterans distal to the tibioperoneal trunk confirmed by Doppler ultrasound, characterized by: disappearance of the normal vascular wall structure, rigidity, enhanced echogenicity, densely arranged arterial calcified plaques within the occluded segment, and absence of blood flow signal in the lumen. 4.6-minute walk test distance <= 400 meters. 5.Fontaine Stage II. 6.Currently receiving standardized guideline-directed medical therapy; 7.Willing and able to provide voluntary, written informed consent;

Exclusion criteria

Exclusion criteria: 1.Presence of any contraindication to EECP: Uncontrolled hypertension (blood pressure >= 180/100 mmHg). Active bleeding disorders or bleeding tendency (e.g., platelet count 2.0). Uncontrolled tachyarrhythmia (e.g., atrial fibrillation, atrial flutter). Moderate to severe aortic regurgitation, aortic aneurysm, or active deep vein thrombosis of the lower limbs. Concurrent active systemic infection, pregnancy, or malignancy. Skin ulceration in the lower limb counterpulsation area, toe gangrene, or active acute infection/hemorrhage in the lower limbs. 2.iliac or femoral artery occlusion; 3.History of lower extremity arterial stenting; 4.Inability or unwillingness to provide written informed consent;

Design outcomes

Primary

MeasureTime frame
Pain-free walking distance;

Secondary

MeasureTime frame
Flow-Mediated Dilation (FMD);6-minute walk test distance;Peak systolic velocity and mean blood flow volume in the distal vasculature beyond the occluded segment, as measured by ultrasonography.;Ankle-Brachial Index (ABI) of the affected limb;Toe transcutaneous oxygen saturation (TcpO?) of the affected limb;

Countries

China

Contacts

Public ContactWenbin Wei

The Eighth Affiliated Hospital Sun Yat-sen University

Weiwb@mail.sysu.edu.cn+86 755 8398 2222

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026