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Recruiting NCT06223217

Development and Validation of the Modified Version of VascuQol Scale in Patients With Lower Extremity Peripheral Arterial Disease.

— Observational Peripheral Arterial Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surveys and Questionnaires.
Who it may be relevant to
Registry conditions: Peripheral Arterial Disease. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The purpose of this study is to assess the utility of the Modified version of VascuQol Scale as an effective biopsychosocial assessment tool for patients suffering from lower extremity peripheral arterial disease.

Detailed description

In the prior study, the original 25-item VascuQol Scale demonstrates the limitation of dimensional mixing. As a result, we suggest improving the original scale by integrating the five dimensions and simplifying the objects. 480 patients will be recruited to complete the Chinese version of VascuQol Scale and the modified version. Reliability, validity, responsiveness, and diagnostic accuracy for CLTI will be used to evaluate whether the modified scale could serve as an effective biopsychosocial assessment tool for patients suffering from lower extremity peripheral arterial disease.

Study Procedures :

After signing the informed consent form, eligible patients and/or their legal guardians will complete the questionnaires.

Outcome measures:

Patient-Reported Outcomes via specific questionnaires

Participant numbers:

480 patients will be recruited

Data management:

Data will be collected directly from the patients. All paper patient records will be kept in locked filing cabinet. Electronic files will be saved on password protected folder

Oversight :

i) Data will be collected in a electric database; ii) all documents containing the identity of the participating subjects (non-objection, list of correspondence, etc.) will be kept away from personal data; iii) If it is a computerized document, it will be kept on the center's information server with access control by password.

Interventions

  • Other Surveys and Questionnaires
    The intervention consists of completing the Chinese version of Vascu-QoL scale and the modified version of Vascu-QoL scale

Primary outcome measures

  • the Modified version of VascuQol Scale [Time frame: pre-operation；1-month；3-month；6-month；12-month]
  • the Chinese version of VascuQol Scale [Time frame: pre-operation；1-month；3-month；6-month；12-month]
Secondary outcome measures (2)
  • Ankle brachial index（ABI） [Time frame: pre-operation；6-month；12-month]
  • EQ-5D-5L Scale [Time frame: pre-operation；1-month；3-month；6-month；12-month]

Eligibility criteria

Inclusion criteria

  • Male or female aged 18-90
  • The patient is diagnosed with lower extremity peripheral arterial disease
  • The patient is willing to comply with specified follow-up evaluations at the specified times
  • The patient understands the nature of the procedure and provides written informed consent before enrolment in the study
  • Before enrolment, the guidewire has crossed the target lesion
  • No restrictions on Rutherford grading, TASC grading, GLASS grading

Exclusion criteria

  • Pregnant women or Female patients with potential childbearing
  • The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
  • Patients unwilling or refusing to sign informed consent
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Renji Hospital — Shanghai

Identifiers

NCT: NCT06223217 · VQL Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗