Assessment of Venous Insufficiency and Clinical Features in Lipedema

Official title

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

Overview

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

• Diagnostic test Venous 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.
• Other Numeric Rating Scale
  Pain intensity will be evaluated using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain).
• Other Lower Extremity Functional Scale
  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.
• Other Short 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.
• Other Lower Extremity Circumference at Standardized Anatomical Landmarks (cm)
  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.
• Other Clinical Staging
  Lipedema stage will be determined according to clinical examination findings and established diagnostic criteria.

Primary outcome measures

• Presence of Venous Reflux on Doppler Ultrasonography [Time frame: Baseline]

Secondary outcome measures (6)

• Pain Severity (NRS) [Time frame: Baseline]
• Lower Extremity Function (LEFS) [Time frame: Baseline]
• Health-Related Quality of Life (SF-12) [Time frame: Baseline]
• Lower Extremity Circumference Measurements [Time frame: Baseline]
• Duration of Venous Reflux on Doppler Ultrasonography [Time frame: Baseline]
• Great Saphenous Vein Diameter Measured by Doppler Ultrasonography [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Turkey (Türkiye) · 1 center

• Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdu — Istanbul

Publications

• Poojari A, Dev K, Rabiee A. Lipedema: Insights into Morphology, Pathophysiology, and Challenges. Biomedicines. 2022 Nov 30;10(12):3081. doi: 10.3390/biomedicines10123081. PMID 36551837
• 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. PMID 34049453
• 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. PMID 33870676
• 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. PMID 38334096
• 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. PMID 38125656
• 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. PMID 37844030
• 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. PMID 35730511
• 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. PMID 40179457

Identifiers

NCT: NCT07603076 · 00000111

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗