Assessing a new tool for evaluating patients with lower extremity peripheral arterial disease
Development and Validation of the Modified Version of VascuQol Scale in Patients With Lower Extremity Peripheral Arterial Disease.
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 |
|---|---|
| Enrollment | 480 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06223217 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While the original VascuQol Scale has been used, the modified version is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Renji Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jingpu Zhu
- Email: a8600809@163.com
- Phone: +86-17520505530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.