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临床试验/NCT07603076
NCT07603076招募中不适用

Evaluation of Venous Insufficiency and Its Association With Clinical Features in Patients With Lipedema: A Cross-Sectional Study

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2026年6月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
82
试验地点
1

研究概览

简要总结

Lipedema is a chronic adipose tissue disorder characterized by disproportionate fat accumulation, pain, tenderness, edema, and functional impairment. Venous symptoms such as heaviness, swelling, and discomfort are frequently reported in individuals with lipedema; however, the relationship between venous Doppler ultrasonography findings and lipedema-related clinical manifestations remains insufficiently investigated. This cross-sectional controlled study aims to evaluate venous insufficiency parameters in patients with lipedema using Doppler ultrasonography and to examine their associations with pain severity, lower extremity function, disease severity, and quality of life.

详细描述

Lipedema is a chronic progressive disorder of subcutaneous adipose tissue that predominantly affects women and is characterized by symmetrical enlargement of the lower extremities, pain, tenderness, easy bruising, and functional limitation. Beyond adipose tissue abnormalities, vascular and microcirculatory alterations have increasingly been implicated in the pathophysiology of the disease. Many individuals with lipedema report symptoms suggestive of venous dysfunction, including leg heaviness, swelling, discomfort, and exercise intolerance. Nevertheless, the clinical significance of venous insufficiency in lipedema has not been fully clarified.This cross-sectional controlled observational study aims to investigate venous insufficiency findings in individuals with lipedema using venous Doppler ultrasonography and to explore their relationship with clinical symptoms and functional status. Venous reflux characteristics, venous diameters, and affected venous segments will be evaluated in the superficial and deep venous systems. These vascular findings will subsequently be analyzed in relation to lipedema severity, pain intensity, lower extremity function, anthropometric measurements, and patient-reported outcomes. By improving the understanding of venous involvement in lipedema, this study may contribute to more comprehensive diagnostic assessment and multidisciplinary management strategies for affected individuals. Patients with lipedema are expected to show more frequent venous insufficiency findings, which may be associated with increased symptom severity and functional limitation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female participants aged 18 years or older
  • Clinically diagnosed lipedema according to established diagnostic criteria
  • Ability to provide written informed consent
  • Ability to complete clinical assessments and questionnaires

排除标准

  • History of lower extremity venous surgery or sclerotherapy
  • Known peripheral arterial disease
  • Secondary lymphedema or other causes of lower extremity edema
  • Active infection, cellulitis, or inflammatory disease affecting the lower extremities
  • Pregnancy or postpartum period
  • Neurological, rheumatological, or musculoskeletal disorders significantly affecting lower extremity function
  • Malignancy or severe systemic disease
  • Inability to undergo venous Doppler ultrasonography
  • Inability to understand or complete study assessments and questionnaires

研究组 & 干预措施

Patient

Patients with lipedema

干预措施: Short Form-12 (Other)

Patient

Patients with lipedema

干预措施: Clinical Staging (Other)

Patient

Patients with lipedema

干预措施: Lower Extremity Circumference at Standardized Anatomical Landmarks (cm) (Other)

Patient

Patients with lipedema

干预措施: Venous Doppler Ultrasonography (Diagnostic Test)

Patient

Patients with lipedema

干预措施: Numeric Rating Scale (Other)

Patient

Patients with lipedema

干预措施: Lower Extremity Functional Scale (Other)

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Feyza Nur Yucel

Assoc.Prof.

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

研究点 (1)

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