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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Patients with lipedema |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous Doppler Ultrasonography | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Venous Reflux on Doppler Ultrasonography | 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Severity (NRS) | 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 |
| Lower Extremity Function (LEFS) |
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Inclusion Criteria:
Exclusion Criteria:
Lipedema predominantly affects women and has a markedly higher prevalence in the female population. Therefore, only female participants will be included in this study to ensure a clinically homogeneous study population.
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feyza Yücel, Assoc. Prof. | Contact | (0216) 542 20 00 | +90 | dr.fny28@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Feyza Yücel, Assoc. Prof. | Sultan 2.Abdülhamid Han Research and Training Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital | Istanbul | Uskudar | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36551837 | Background | Poojari A, Dev K, Rabiee A. Lipedema: Insights into Morphology, Pathophysiology, and Challenges. Biomedicines. 2022 Nov 30;10(12):3081. doi: 10.3390/biomedicines10123081. | |
| 34049453 | Background | 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. |
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Individual participant data will not be made publicly available due to privacy and confidentiality considerations.
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|
| Numeric Rating Scale | Other | Pain intensity will be evaluated using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain). |
|
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| Lower Extremity Functional Scale | Other | 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. |
|
|
| Short Form-12 | Other | 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. |
|
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| Circumference Measurements | Other | Lower extremity circumferences will be measured at predefined anatomical landmarks to evaluate limb involvement |
|
| Clinical Staging | Other | Lipedema stage will be determined according to clinical examination findings and established diagnostic criteria. |
|
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) | 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. | Baseline |
| Lower Extremity Circumference Measurements | Lower extremity circumferences will be measured at predefined anatomical landmarks to evaluate limb involvement and tissue distribution. | Baseline |
| Duration of Venous Reflux on Doppler Ultrasonography | Reflux duration (milliseconds) in great saphenous vein will be recorded according to standard venous ultrasound criteria. | Baseline |
| Great Saphenous Vein Diameter Measured by Doppler Ultrasonography | 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 |
| 33870676 | Background | 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. |
| 38334096 | Background | 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. |
| 38125656 | Background | 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. |
| 37844030 | Background | 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. |
| 35730511 | Background | 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. |
| 40179457 | Background | 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. |
| ID | Term |
|---|---|
| D065134 | Lipedema |
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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