Clinical trial NCT06223217: Development and Validation of the Modified Version of VascuQol Scale in 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: First Affiliated Hospital of Zhejiang University
name: First People's Hospital of Hangzhou
name: Huashan Hospital
name: Hospital of Chengdu University of TCM
First posted: 2024-01-25
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient is diagnosed with lower extremity peripheral arterial disease and no restrictions on Rutherford grading, TASC grading, GLASS grading.

Brief summary: 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.

Eligibility 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

Primary outcomes:
measure: the Modified version of VascuQol Scale
timeFrame: pre-operation；1-month；3-month；6-month；12-month
measure: the Chinese version of VascuQol Scale
timeFrame: pre-operation；1-month；3-month；6-month；12-month
Secondary outcomes:
measure: Ankle brachial index（ABI）
timeFrame: pre-operation；6-month；12-month
measure: EQ-5D-5L Scale
timeFrame: pre-operation；1-month；3-month；6-month；12-month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References: