Assessing a new tool for evaluating patients with lower extremity peripheral arterial disease
Official title: Development and Validation of the Modified Version of VascuQol Scale in Patients With Lower Extremity Peripheral Arterial Disease.
Run by RenJi Hospital · NCT06223217 · Data updated 2026-11-12
This study is testing a new questionnaire to see if it helps better understand the needs of people with lower extremity peripheral arterial disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 480 (estimated) |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | October 1, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | January 25, 2024 |
| Trial ID | NCT06223217 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include males and females aged 18-90 diagnosed with lower extremity peripheral arterial disease who can comply with follow-up evaluations.
✕Probably not a fit
Patients with other serious diseases affecting quality of life or those currently participating in other investigational studies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the Modified version of the VascuQol Scale as a biopsychosocial assessment tool for patients with lower extremity peripheral arterial disease. A total of 480 patients will be recruited to complete both the original and modified versions of the scale. The study will assess the reliability, validity, responsiveness, and diagnostic accuracy of the modified scale. Data will be collected through questionnaires, and patient confidentiality will be maintained throughout the process.
Why it matters
Potential benefit: If successful, this study could provide a more effective assessment tool for understanding the impact of peripheral arterial disease on patients' quality of life.
How similar studies have gone: While the original VascuQol Scale has been used, the modified version is a novel approach that has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female aged 18-90 2. The patient is diagnosed with lower extremity peripheral arterial disease 3. The patient is willing to comply with specified follow-up evaluations at the specified times 4. The patient understands the nature of the procedure and provides written informed consent before enrolment in the study 5. Before enrolment, the guidewire has crossed the target lesion 6. No restrictions on Rutherford grading, TASC grading, GLASS grading Exclusion Criteria: 1. Pregnant women or Female patients with potential childbearing 2. The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint. 3. Patients unwilling or refusing to sign informed consent 4. Patients with other diseases that may seriously affect the quality of life, such as tumors, severe liver disease, cardiac insufficiency, etc., or those with a life expectancy of less than 2 years
Where it's running
-
Renji Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Jingpu Zhu
- Email: a8600809@163.com
- Phone: +86-17520505530
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.