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

NCT05519176 | Completed

• 1 other identifier: YXLL-KY-2022(053)
• Study Type: observational
• Target: 1,234
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Ulceration

Keywords

Varicose Veins; Varicose Ulcer; Leg Ulcer; Case-Control Study

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Clinical diagnosis of varicose veins of the lower extremities
• Hospitalized patients
• years old or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Yibing Wang: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Varicose Ulcer; Varicose Veins; Leg Ulcer

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Wang Yibing, Doctor

  The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 29, 2022
• Study Start: January 1, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

CN (1)