Assessment of Venous Insufficiency and Clinical Features in Lipedema

NCT07603076 | Not Yet Recruiting

• 1 other identifier: 00000111
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipedema; Venous Insufficiency; Venous Disease; Disability Physical

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Pain Severity (NRS)

  Baseline

• Lower Extremity Function (LEFS)

  Baseline

• Health-Related Quality of Life (SF-12)

  Baseline

• Lower Extremity Circumference Measurements

  Baseline

• Duration of Venous Reflux on Doppler Ultrasonography

  Baseline

Study Arms (1)

Patient

Patients with lipedema

Diagnostic Test: Venous Doppler Ultrasonography; Other: Numeric Rating Scale; Other: Lower Extremity Functional Scale; Other: Short Form-12; Other: Circumference Measurements; Other: Clinical Staging

Interventions

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.

Patient

Numeric Rating Scale OTHER

Pain intensity will be evaluated using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain).

Also known as: NRS

Patient

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.

Also known as: LEFS

Patient

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.

Also known as: SF-12

Patient

Circumference Measurements OTHER

Lower extremity circumferences will be measured at predefined anatomical landmarks to evaluate limb involvement

Patient

Clinical Staging OTHER

Lipedema stage will be determined according to clinical examination findings and established diagnostic criteria.

Patient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Location

Related Publications (8)

• 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 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.

  PMID: 34049453 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.

  PMID: 33870676 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.

  PMID: 38334096 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.

  PMID: 38125656 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.

  PMID: 37844030 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.

  PMID: 35730511 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.

  PMID: 40179457 BACKGROUND

MeSH Terms

Conditions

Lipedema; Venous Insufficiency

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Feyza Yücel, Assoc. Prof.

  Sultan 2.Abdülhamid Han Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feyza Yücel, Assoc. Prof.

CONTACT

(0216) 542 20 00; dr.fny28@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 22, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)