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

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.

Study Overview

• Status: Completed
• Conditions: Venous Ulceration

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 Type: Observational
• Enrollment (Actual): 1234

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yibing Wang
• Investigators: Principal Investigator: Wang Yibing, Doctor, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Varicose Veins; Leg Ulcer; Varicose Ulcer; Case-Control Study
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Ulcer; Varicose Ulcer; Varicose Veins
• Other Study ID Numbers: YXLL-KY-2022(053)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No