Peripheral Arterial DiseaseNCT06223217
Development and Validation of the Modified Version of VascuQol Scale in Patients With Lower Extremity Peripheral Arterial Disease.
An observational study of Peripheral Arterial Disease, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Surveys and Questionnaires
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient is diagnosed with lower extremity peripheral arterial disease and no restrictions on Rutherford grading, TASC grading, GLASS grading.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality
Jingpu Zhu, +86-17520505530, a8600809@163.com
Lan Zhang, MD
About this study
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.
Read the 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 :
- 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Surveys and Questionnaires
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surveys and QuestionnairesOther
The intervention consists of completing the Chinese version of Vascu-QoL scale and the modified version of Vascu-QoL scale
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Patients who undergoing endoluminal treatment for lower extremity peripheral arterial disease will complete the Modified version of the VascuQoL scale, the Chinese version of the VascuQoL scale, EQ-5D-5L Scale and the ABI test according to follow-up plan. Receives: Other: Surveys and Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Modified version of VascuQol Scale
It is one of the frequently used scales to measure quality of life in patients with lower extremity arterial disease. It evaluates 5 different categories such as the symptom, social, activity, pain and emotional with a total of 25 sub-items. A 7-point Likert system is used to score this scale. It is sufficient for each item to check the corresponding boxes. In Modified version，we adjusted the questionnaire items and structure based on the the Chinese version and results of the previous reserach.
Measured: pre-operation；1-month；3-month；6-month；12-month
the Chinese version of VascuQol Scale
It is one of the frequently used scales to measure quality of life in patients with lower extremity arterial disease. It evaluates 5 different categories such as the symptom, social, activity, pain and emotional with a total of 25 sub-items. A 7-point Likert system is used to score this scale. It is sufficient for each item to check the corresponding boxes. In Chinese version，not only did we complete cultural adaptation, but we used the emoji-based visual analogue scale to help patients fill out the scales.
Measured: pre-operation；1-month；3-month；6-month；12-month
Secondary outcomes (2)
Ankle brachial index（ABI）
The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). Compared to the arm, lower blood pressure in the leg suggests blocked arteries due to peripheral artery disease (PAD). The ABPI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm.
Measured: pre-operation；6-month；12-month
EQ-5D-5L Scale
EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition.
Measured: pre-operation；1-month；3-month；6-month；12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, First Affiliated Hospital of Zhejiang University, First People's Hospital of Hangzhou, Huashan Hospital, Hospital of Chengdu University of TCM
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223217
- Sponsor's protocol ID
- VQL Study
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Modified Version of VascuQol Scale in Patients With Lower Extremity Peripheral Arterial Disease.
- ClinicalTrials.gov ID
- NCT06223217
- Acronym / sponsor ID
- VQL Study
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, First Affiliated Hospital of Zhejiang University, First People's Hospital of Hangzhou, Huashan Hospital, Hospital of Chengdu University of TCM
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experiment group | – | Other: Surveys and QuestionnairesPatients who undergoing endoluminal treatment for lower extremity peripheral arterial disease will complete the Modified version of the VascuQoL scale, the Chinese version of the VascuQoL scale, EQ-5D-5L Scale and the ABI test according to follow-up plan. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient is diagnosed with lower extremity peripheral arterial disease and no restrictions on Rutherford grading, TASC grading, GLASS grading.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surveys and QuestionnairesThe intervention consists of completing the Chinese version of Vascu-QoL scale and the modified version of Vascu-QoL scale | Other | Experiment group |
Primary outcome
the Modified version of VascuQol Scale
Time frame: pre-operation；1-month；3-month；6-month；12-month
It is one of the frequently used scales to measure quality of life in patients with lower extremity arterial disease. It evaluates 5 different categories such as the symptom, social, activity, pain and emotional with a total of 25 sub-items. A 7-point Likert system is used to score this scale. It is sufficient for each item to check the corresponding boxes. In Modified version，we adjusted the questionnaire items and structure based on the the Chinese version and results of the previous reserach.
the Chinese version of VascuQol Scale
Time frame: pre-operation；1-month；3-month；6-month；12-month
It is one of the frequently used scales to measure quality of life in patients with lower extremity arterial disease. It evaluates 5 different categories such as the symptom, social, activity, pain and emotional with a total of 25 sub-items. A 7-point Likert system is used to score this scale. It is sufficient for each item to check the corresponding boxes. In Chinese version，not only did we complete cultural adaptation, but we used the emoji-based visual analogue scale to help patients fill out the scales.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingpu Zhu (+86-17520505530, a8600809@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Modified version of VascuQol Scale (time frame: pre-operation；1-month；3-month；6-month；12-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.