Clinical trial Recruiting at 1 site Observational Ages 18 to 90

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 typeObservational
Ages18 Years to 90 Years
SexAll
Enrollment480 (estimated)
SponsorRenJi Hospital
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedOctober 1, 2023
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedJanuary 25, 2024
Trial IDNCT06223217 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.