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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
観察的
入学 (推定)
82
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Feyza Yücel, Assoc. Prof.
- 電話番号：+90 (0216) 542 20 00
- メール：dr.fny28@gmail.com
研究場所
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Uskudar
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Istanbul、Uskudar、トルコ（Türkiye）
- 募集
- Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital
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コンタクト：
- Feyza Yücel, Assoc.Prof.
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副調査官：
- Şule Dayanç
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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).
他の名前：
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.
他の名前：
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.
他の名前：
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Presence of Venous Reflux on Doppler Ultrasonography
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Severity (NRS)
時間枠：Baseline
|
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)
時間枠：Baseline
|
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
|
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Health-Related Quality of Life (SF-12)
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline
|
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.
|
Baseline
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Feyza Yücel, Assoc. Prof.、Sultan 2.Abdülhamid Han Research and Training Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月20日
一次修了 (推定)
2026年7月30日
研究の完了 (推定)
2026年8月1日
試験登録日
最初に提出
2026年5月10日
QC基準を満たした最初の提出物
2026年5月17日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月14日
QC基準を満たした最後の更新が送信されました
2026年7月13日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be made publicly available due to privacy and confidentiality considerations.
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