Skip to content

Self-management intervention in patient with lower extremity arterial disease underwent endovascular treatment

Self-management scale development of patient with lower extremity arterial disease underwent endovascular treatment and a self-management intervention research

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068966
Enrollment
Unknown
Registered
2023-03-02
Start date
2021-02-07
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

lower extremity arterial disease

Interventions

Low-risk intervention group:Self-management intervention
Low-risk control group:Usual health education
High-risk intervention group:Self-management intervention
High-risk control group:Usual health education

Sponsors

Innovation Center of Nursing Research, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. In accordance with the diagnostic criteria of ‘’Guidelines for Diagnosis and Treatment of Arteriosclerosis Obliterans of Lower Limbs’’ : (1) Aged > 40 years; Clinical manifestations of arteriosclerosis obliterans of lower extremity; (2) Clinical manifestations of ASO in lower extremities; (3) The distal artery pulsation of the ischemic limb was weakened or disappeared; (4) ABI<=0.9; (5) Color Doppler ultrasonography, CTA, MRA, DSA and other imaging examinations showed that stenosis or occlusion of corresponding arteries was confirmed as arteriosclerosis obliterans of lower limbs. 2. Patients who met the indication standards for vascular interventional surgery and successfully underwent vascular interventional surgery for the first time in hospital (two interventional surgeons jointly judged that the rate of residual vascular stenosis was less than 30% as successful surgery). The surgical procedures included percutaneous balloon dilatation PTA, PTA combined with stent implantation, medical balloon, cutting balloon, medical stent, plaque autotomy, and non-open procedures such as drug thrombolytic therapy or thrombectomy. 3. Clear consciousness, no mental disorder or cognitive dysfunction, able to interact with medical staff, able to understand the content of the questionnaire, and answer independently. 4. Informed consent of the patient, voluntary participation, regular review and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with severe liver disease, severe coagulopathy or malignant tumor; 2. Patients diagnosed as arteriosclerotic obliterans of lower limbs before surgery and corrected as thromboangiitis obliterans (Berg's disease) after surgery; 3. Life expectancy <1 year; 4. Patients who are allergic to anticoagulant/antiplatelet therapy; 5. Those who did not meet the inclusion criteria after enrollment (such as those who had received lower extremity arterial vascular interventional surgery, bypass surgery and open surgery); 6. Unable to follow the plan; 7. Patients who have participated in other clinical trials within the previous 3 months.

Design outcomes

Primary

MeasureTime frame
Restenosis rate;

Secondary

MeasureTime frame
Self-management ability;Quality of life;Cost-utility;6-minute maximum walking distance;Readmission rate;Major adverse cardiac events rate;Target lesion revascularization;Bilateral endovascular therapy;Mortality;Amputation rate;Complete wound healing rate;

Countries

China

Contacts

Public ContactHu Xiuying

Innovation Center of Nursing Research, West China Hospital, Sichuan University

westchinahuxiuying@163.com+86 189 8060 1178

Outcome results

None listed

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