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OpenTrials
Completed

NCT Number: NCT05519176

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Jinan, Shandong, 250014, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Yibing Wang

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2022
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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