A Study of Risk Factors for Venous Ulceration in Patients With Varicose Veins of Lower Extremities.

Venous Ulceration Clinical Trial

Official title:

A Study of Risk Factors for Venous Ulceration in Patients With Varicose Veins of Lower Extremities: A Case-control Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05519176
• Other study ID #: YXLL-KY-2022(053)
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2024
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1234
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of varicose veins of the lower extremities

2. Hospitalized patients

3. 18 years old or older

Exclusion Criteria:

1. Patients with any other conditions that could also lead to venous ulceration including peripheral artery disease, diabetes, and pressure ulcers

2. Patients with heart, liver and kidney failure

3. Patients with malignant tumor

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Varicose Veins
• Venous Ulceration

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yibing Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2016-2020