ClinicalTrials.gg
RecruitingNCT07603076Updated Jul 14, 2026

Assessment of Venous Insufficiency and Clinical Features in Lipedema

An observational study in Lipedema, Venous Insufficiency and Venous Disease, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jun 2026; still recruiting 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
82
Ages
18 Years to 65 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 41 studies in Lipedema with a site in Turkey — 18 open to participants now, 19 under way, none of them phase 3. Lipedema · Turkey.

Planned enrollment
13th of 27
82 · median 76
Started
2026
with 17 others
Observational
27 of 41
9 open now
Primary completion
2026-07
later than 5 of 18 live
Registered
27th of 41
by date
Lead sponsor
4 of 41
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Among the 41 studies in Lipedema with a site in Turkey, this one is the 13th largest by planned enrollment of the 27 observational ones, is one of 18 that started in 2026, is one of 27 observational ones, reaches primary completion later than 5 of the 18 other live ones, and was the 27th registered.

By phase

41 studies; the count open now beside each. This study's row is marked.

Observationalthis study27 · 9 open
No phase14 · 9 open

By the year they started

First in 2019; this study’s year is marked. 18 started in 2026.

Size and results

Median enrollment 37 across the 14 interventional studies, 76 across the 27 observational. Of the 22 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 41 studies in Lipedema with a site in Turkey, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Lipedema
  • Venous Insufficiency
  • Venous Disease
  • Disability Physical
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female participants aged 18 years or older
  • Clinically diagnosed lipedema according to established diagnostic criteria
  • Ability to provide written
  • Ability to complete clinical assessments and questionnaires

Exclusion criteria

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
  • or severe systemic disease
  • Inability to undergo venous Doppler ultrasonography
  • Inability to understand or complete study assessments and questionnaires
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
82 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient

    Patients with lipedema

    Diagnostic Test: Venous Doppler Ultrasonography · Other: Numeric Rating Scale · Other: Lower Extremity Functional Scale · Other: Short Form-12 · Other: Lower Extremity Circumference at Standardized Anatomical Landmarks (cm) · Other: Clinical Staging

Interventions

  • 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).

    Also known as: NRS

  • OtherLower 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.

    Also known as: LEFS

  • 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.

    Also known as: SF-12

  • OtherLower 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.

  • OtherClinical Staging

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

06

What researchers measure

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.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. Lower Extremity Function (LEFS)

    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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. Lower Extremity Circumference Measurements

    Lower extremity circumferences will be measured at predefined anatomical landmarks to evaluate limb involvement and tissue distribution.

    Time frame: Baseline

  5. Duration of Venous Reflux on Doppler Ultrasonography

    Reflux duration (milliseconds) in great saphenous vein will be recorded according to standard venous ultrasound criteria.

    Time frame: Baseline

  6. 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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital
    Istanbul, Uskudar, Turkey (Türkiye)
    Recruiting
    • Feyza Yücel, Assoc.Prof. · Contact
    • Şule Dayanç · Sub investigator
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 40179457 ↗

Individual participant data

Plan to share: No — Individual participant data will not be made publicly available due to privacy and confidentiality considerations.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for Jul 2026, 1 month after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2026
First posted
May 22, 2026
StartActual
Jun 20, 2026
Primary completionEst.
Jul 30, 2026
CompletionEst.
Aug 1, 2026
Last update
Jul 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07603076
Responsible party
Feyza Nur Yucel (Assoc.Prof., Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey) — Principal investigator
First posted
May 22, 2026
Start date
Jun 20, 2026
Primary completion
Jul 30, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Jul 14, 2026

Study contacts

Feyza Yücel, Assoc. Prof.
Contact
dr.fny28@gmail.com
(0216) 542 20 00 ext. +90
Feyza Yücel, Assoc. Prof.
principal investigator · Sultan 2.Abdülhamid Han Research and Training Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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