Assessment of Venous Insufficiency and Clinical Features in Lipedema
2026年7月13日 更新者:Feyza Nur Yucel、Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Evaluation of Venous Insufficiency and Its Association With Clinical Features in Patients With Lipedema: A Cross-Sectional Study
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.
研究概览
地位
招聘中
详细说明
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.
研究类型
观察性的
注册 (估计的)
82
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Feyza Yücel, Assoc. Prof.
- 电话号码:+90 (0216) 542 20 00
- 邮箱:dr.fny28@gmail.com
学习地点
-
-
Uskudar
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Istanbul、Uskudar、土耳其(türkiye)
- 招聘中
- Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital
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接触:
- Feyza Yücel, Assoc.Prof.
-
副研究员:
- Şule Dayanç
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
The study population will consist of adult female patients diagnosed with lipedema.
Participants with lipedema will be recruited from the outpatient physical medicine and rehabilitation clinic.
All participants will undergo clinical assessment and lower extremity venous Doppler ultrasonography.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Patient
Patients with lipedema
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Participants will undergo lower extremity venous Doppler ultrasonography to evaluate venous insufficiency findings, including venous reflux characteristics, affected venous segments, and venous diameters in the superficial and deep venous systems.
Pain intensity will be evaluated using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain).
其他名称:
Functional status will be assessed using the Lower Extremity Functional Scale.
The total score ranges from 0 to 80, with higher scores indicating better lower extremity function and lower disability levels.
其他名称:
Health-related quality of life will be assessed using the SF-12 questionnaire, including the Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores.
Scores range from 0 to 100, with higher scores indicating better perceived health status and quality of life.
其他名称:
Lipedema stage will be determined according to clinical examination findings and established diagnostic criteria.
Circumference of both lower extremities will be measured using a non-stretch tape measure at the ankle, calf, knee, and thigh according to standardized anatomical landmarks.
Measurements will be recorded in centimeters.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Presence of Venous Reflux on Doppler Ultrasonography
大体时间:Baseline
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Venous reflux will be assessed using lower extremity venous Doppler ultrasonography.
The presence of pathological reflux in great saphenous vein will be recorded according to standard venous ultrasound criteria.
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Baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain Severity (NRS)
大体时间:Baseline
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Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain severity.
|
Baseline
|
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Lower Extremity Function (LEFS)
大体时间:Baseline
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Lower extremity function will be evaluated using the Lower Extremity Functional Scale (LEFS).
Total scores range from 0 to 80, with higher scores indicating better functional status and lower disability levels.
|
Baseline
|
|
Health-Related Quality of Life (SF-12)
大体时间:Baseline
|
Health-related quality of life will be assessed using the Short Form-12 (SF-12) questionnaire, including Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores.
Scores range from 0 to 100, with higher scores indicating better quality of life and perceived health status.
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Baseline
|
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Lower Extremity Circumference Measurements
大体时间:Baseline
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Lower extremity circumferences will be measured at predefined anatomical landmarks to evaluate limb involvement and tissue distribution.
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Baseline
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Duration of Venous Reflux on Doppler Ultrasonography
大体时间:Baseline
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Reflux duration (milliseconds) in great saphenous vein will be recorded according to standard venous ultrasound criteria.
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Baseline
|
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Great Saphenous Vein Diameter Measured by Doppler Ultrasonography
大体时间:Baseline
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The diameter of the great saphenous vein will be measured in millimeters using lower extremity venous Doppler ultrasonography.
Measurements will be recorded at predefined anatomical levels.
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Baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Feyza Yücel, Assoc. Prof.、Sultan 2.Abdülhamid Han Research and Training Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.
- Herbst KL, Kahn LA, Iker E, Ehrlich C, Wright T, McHutchison L, Schwartz J, Sleigh M, Donahue PM, Lisson KH, Faris T, Miller J, Lontok E, Schwartz MS, Dean SM, Bartholomew JR, Armour P, Correa-Perez M, Pennings N, Wallace EL, Larson E. Standard of care for lipedema in the United States. Phlebology. 2021 Dec;36(10):779-796. doi: 10.1177/02683555211015887. Epub 2021 May 28.
- Forner-Cordero I, Forner-Cordero A, Szolnoky G. Update in the management of lipedema. Int Angiol. 2021 Aug;40(4):345-357. doi: 10.23736/S0392-9590.21.04604-6. Epub 2021 Apr 19.
- Poojari A, Dev K, Rabiee A. Lipedema: Insights into Morphology, Pathophysiology, and Challenges. Biomedicines. 2022 Nov 30;10(12):3081. doi: 10.3390/biomedicines10123081.
- Khalid MU, Prasada S, Jennings C, Bartholomew JR, McCarthy M, Hornacek DA, Joseph D, Chen W, Schwarz G, Bhandari R, Elbadawi A, Cameron SJ. Venous thromboembolic outcomes in patients with lymphedema and lipedema: An analysis from the National Inpatient Sample. Vasc Med. 2024 Feb;29(1):42-47. doi: 10.1177/1358863X231219006.
- Bindlish S, Ng J, Ghusn W, Fitch A, Bays HE. Obesity, thrombosis, venous disease, lymphatic disease, and lipedema: An obesity medicine association (OMA) clinical practice statement (CPS) 2023. Obes Pillars. 2023 Oct 19;8:100092. doi: 10.1016/j.obpill.2023.100092. eCollection 2023 Dec.
- Aday AW, Donahue PM, Garza M, Crain VN, Patel NJ, Beasley JA, Herbst KL, Beckman JA, Taylor SL, Pridmore M, Chen SC, Donahue MJ, Crescenzi R. National survey of patient symptoms and therapies among 707 women with a lipedema phenotype in the United States. Vasc Med. 2024 Feb;29(1):36-41. doi: 10.1177/1358863X231202769. Epub 2023 Oct 16.
- Kara-Cakici G, Can-Akman T, Uzun SU, Cetisli-Korkmaz N. Validity and reliability study of the Turkish version of the Lower Extremity Functional Scale in elderly adults. Braz J Phys Ther. 2025 May-Jun;29(3):101196. doi: 10.1016/j.bjpt.2025.101196. Epub 2025 Apr 2.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月20日
初级完成 (估计的)
2026年7月30日
研究完成 (估计的)
2026年8月1日
研究注册日期
首次提交
2026年5月10日
首先提交符合 QC 标准的
2026年5月17日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年7月14日
上次提交的符合 QC 标准的更新
2026年7月13日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.