Lipedema, Venous Insufficiency, Venous Disease, Disability Physical
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERCircumference Measurements
Lower extremity circumferences will be measured at predefined anatomical landmarks to evaluate limb involvement
OTHERClinical Staging
Lipedema stage will be determined according to clinical examination findings and established diagnostic criteria.
DIAGNOSTIC_TESTVenous Doppler Ultrasonography
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.
OTHERNumeric Rating Scale
Pain intensity will be evaluated using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain).
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.
OTHERShort Form-12
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.
Sponsors
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Venous Reflux on Doppler Ultrasonography | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity (NRS) | 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. |
| Lower Extremity Function (LEFS) | 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. |
| Health-Related Quality of Life (SF-12) | 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. |
| Lower Extremity Circumference Measurements | Baseline | Lower extremity circumferences will be measured at predefined anatomical landmarks to evaluate limb involvement and tissue distribution. |
| Duration of Venous Reflux on Doppler Ultrasonography | Baseline | Reflux duration (milliseconds) in great saphenous vein will be recorded according to standard venous ultrasound criteria. |
| Great Saphenous Vein Diameter Measured by Doppler Ultrasonography | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTFeyza Yücel, Assoc. Prof.
PRINCIPAL_INVESTIGATORFeyza Yücel, Assoc. Prof.
Sultan 2.Abdülhamid Han Research and Training Hospital
Outcome results
None listed