Venous UlcerationNCT05519176
A Study of Risk Factors for Venous Ulceration in Patients With Varicose Veins of Lower Extremities.
An observational study of Venous Ulceration, run by Yibing Wang at 1 site in China.
Trial summary
Varicose veins of lower extremities can lead to adverse consequences such as ulceration and hemorrhage, which seriously endangering the physical and mental health and quality of life for patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulceration
- How many people
- 1,234 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cases and controls are inpatients with varicose veins of lower extremities in The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital between January 1, 2016 and December 31, 2020.
Who may be able to join
- Clinical diagnosis of varicose veins of the lower extremities
- Hospitalized patients
- 18 years old or older
Who cannot join
- Patients with any other conditions that could also lead to venous ulceration including peripheral artery disease, diabetes, and pressure ulcers
- Patients with heart, liver and kidney failure
- Patients with malignant tumor
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014
About this study
Official title: A Study of Risk Factors for Venous Ulceration in Patients With Varicose Veins of Lower Extremities: A Case-control Study.
Varicose veins of lower extremities can lead to adverse consequences such as ulceration and hemorrhage, which seriously endangering the physical and mental health and quality of life for patients.
The aim of this study is to explore the potential risk factors of venous ulceration in patients with varicose veins of lower extremities based on a case-control study, and to provide a reference for personalized treatment.
Read the detailed description
Varicose veins of lower extremities are common chronic diseases. The main clinical manifestations are lower extremity weakness, heaviness, burning sensation, itching, swelling or pain, and severe cases are often accompanied by complications such as changes in skin color, ulceration and hemorrhage. Venous ulceration is one of the main complications of lower extremity varicose veins, accounting for more than 75% of all lower extremity ulcers. Venous ulceration are difficult to heal and prone to recurrence. Studies have shown that the recurrence rate of venous ulceration is as high as 67%. The refractory and high recurrence rate of venous ulceration not only have a serious impact on the quality of patients' life, but also bring a heavy economic burden on society.
Venous ulceration in varicose veins of lower extremities patients may linked to different causes, including past medical history, comorbidity, inflammatory response, etc. The purpose of this study is to collect demographic characteristics, lifestyle characteristics, laboratory indicators, past history, comorbidity and other information by using the data set of patients with varicose veins of lower extremities based on the Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform. To explore the potential risk factors of venous ulceration in patients with varicose veins of lower extremities through case-control study.
- Conditions
- Venous Ulceration
- Keywords
- Varicose Veins, Varicose Ulcer, Leg Ulcer, Case-Control Study
- Medical subject headings
- Varicose Ulcer, Varicose Veins, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Varicose veins of lower extremities inpatients with venous ulceration from The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital. | |
| Controls | Varicose veins of lower extremities inpatients without venous ulceration from The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds ratios of risk factors for venous ulceration
Age, gender, diastolic blood pressure, systolic blood pressure, routine blood indexes, coagulation indexes, duration of varicose veins of lower extremities, height, weight, smoking and drinking, comorbidity, family history of venous diseases, usage in anticoagulants and antihypertensives are all the possible risk factors of venous ulceration.
Measured: 2016-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Jan 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcerationStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yibing Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yibing Wang, Qianfoshan Hospital
- Investigators
- Wang Yibing, Doctor, Principal investigator, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519176
- Sponsor's protocol ID
- YXLL-KY-2022(053)
- Status last verified
- Apr 2024
- First submitted
- 26 Aug 2022
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Risk Factors for Venous Ulceration in Patients With Varicose Veins of Lower Extremities: A Case-control Study.
- ClinicalTrials.gov ID
- NCT05519176
- Acronym / sponsor ID
- YXLL-KY-2022(053)
- Conditions
- Venous Ulceration
- Keywords
- Varicose Veins, Varicose Ulcer, Leg Ulcer, Case-Control Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,234 participants (actual)
- Lead sponsor
- Yibing WangUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Aug 2022 (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.
Varicose veins of lower extremities can lead to adverse consequences such as ulceration and hemorrhage, which seriously endangering the physical and mental health and quality of life for patients.
The aim of this study is to explore the potential risk factors of venous ulceration in patients with varicose veins of lower extremities based on a case-control study, and to provide a reference for personalized treatment.
Detailed description
Varicose veins of lower extremities are common chronic diseases. The main clinical manifestations are lower extremity weakness, heaviness, burning sensation, itching, swelling or pain, and severe cases are often accompanied by complications such as changes in skin color, ulceration and hemorrhage. Venous ulceration is one of the main complications of lower extremity varicose veins, accounting for more than 75% of all lower extremity ulcers. Venous ulceration are difficult to heal and prone to recurrence. Studies have shown that the recurrence rate of venous ulceration is as high as 67%. The refractory and high recurrence rate of venous ulceration not only have a serious impact on the quality of patients' life, but also bring a heavy economic burden on society.
Venous ulceration in varicose veins of lower extremities patients may linked to different causes, including past medical history, comorbidity, inflammatory response, etc. The purpose of this study is to collect demographic characteristics, lifestyle characteristics, laboratory indicators, past history, comorbidity and other information by using the data set of patients with varicose veins of lower extremities based on the Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform. To explore the potential risk factors of venous ulceration in patients with varicose veins of lower extremities through case-control study.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Varicose veins of lower extremities inpatients with venous ulceration from The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital. |
| Controls | – | –Varicose veins of lower extremities inpatients without venous ulceration from The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases and controls are inpatients with varicose veins of lower extremities in The First Affiliated Hospital of Shandong First Medical University \& Shandong Provincial Qianfoshan Hospital between January 1, 2016 and December 31, 2020.
Key inclusion criteria (3 listed)
- Clinical diagnosis of varicose veins of the lower extremities
- Hospitalized patients
- 18 years old or older
Key exclusion criteria (3 listed)
- Patients with any other conditions that could also lead to venous ulceration including peripheral artery disease, diabetes, and pressure ulcers
- Patients with heart, liver and kidney failure
- Patients with malignant tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Odds ratios of risk factors for venous ulceration
Time frame: 2016-2020
Age, gender, diastolic blood pressure, systolic blood pressure, routine blood indexes, coagulation indexes, duration of varicose veins of lower extremities, height, weight, smoking and drinking, comorbidity, family history of venous diseases, usage in anticoagulants and antihypertensives are all the possible risk factors of venous ulceration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Wang Yibing, Doctor principal investigator
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
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 Venous Ulceration, run by Yibing Wang 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 26 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odds ratios of risk factors for venous ulceration (time frame: 2016-2020). 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 26 Apr 2024.