Assessment of Venous Insufficiency and Clinical Features in Lipedema
13. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
82
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Feyza Yücel, Assoc. Prof.
- Telefonnummer: +90 (0216) 542 20 00
- E-post: dr.fny28@gmail.com
Studiesteder
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Uskudar
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Istanbul, Uskudar, Tyrkia (Türkiye)
- Rekruttering
- Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital
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Ta kontakt med:
- Feyza Yücel, Assoc.Prof.
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Underetterforsker:
- Şule Dayanç
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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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).
Andre navn:
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.
Andre navn:
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.
Andre navn:
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Presence of Venous Reflux on Doppler Ultrasonography
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Pain Severity (NRS)
Tidsramme: 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.
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Baseline
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Lower Extremity Function (LEFS)
Tidsramme: 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.
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Baseline
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Health-Related Quality of Life (SF-12)
Tidsramme: Baseline
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Feyza Yücel, Assoc. Prof., Sultan 2.Abdülhamid Han Research and Training Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. juni 2026
Primær fullføring (Antatt)
30. juli 2026
Studiet fullført (Antatt)
1. august 2026
Datoer for studieregistrering
Først innsendt
10. mai 2026
Først innsendt som oppfylte QC-kriteriene
17. mai 2026
Først lagt ut (Faktiske)
22. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 00000111
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be made publicly available due to privacy and confidentiality considerations.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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