Clinical trial NCT06238791: Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease
Official title: Static Plantar Pressure Distribution and Presence of Foot Deformities in Patients With Lipedema and Chronic Venous Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Venous Insufficiency
Lipedema
Keywords: Foot deformity
venous insufficiency
pressure
Lipedema
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients were divided into two groups: Patients with only CVD and patients with CVD accompanied lipedema.

Brief summary: Chronic venous disease (CVD) are common vascular pathology characterized by a wide spectrum of clinical manifestations occurring with symptoms and/or signs that vary in type and severity. The pathophysiological mechanisms of CVD start from the development of venous hypertension, leading to endothelial dysfunction and venous wall dilatation. Lipedema is subcutaneous adipose tissue disorder characterized by enlargement of both lower extremities. Previous studies showed that foot deformities such as pes planus or cavus are at a high prevalence in CVD patients, and the authors indicated that foot disorders are an important risk factor that negatively affects venous disease. To the best of our knowledge, there is only one study investigating plantar arch abnormalities in lipedema patients based on clinical observation. Therefore, the study aimed to investigate plantar foot distribution and foot deformity in patients with CVD and lipedema.


Eligibility criteria: Inclusion Criteria:

* diagnosed with CVD or CVD combined with lipedema,
* The clinic (C) score of clinical, etiological, anatomical, pathophysiological (CEAP) classification was C1, C2 or C3 (C1: telangiectasia-reticular vein; C2: varicose vein; C3: edema)

Exclusion Criteria:

* C4, C5 or C6 (presence of skin changes or ulcer) in C score of CEAP classification
* undergone lower extremity orthopedic surgery within the last year,
* have peripheral artery disease
* patients who could not mobilize independently

Primary outcomes:
measure: The presence of foot deformity
timeFrame: baseline of study
measure: Plantar pressure distribution
timeFrame: baseline of study
Secondary outcomes:
measure: Ankle range of motion
timeFrame: baseline of study
measure: Foot posture
timeFrame: baseline of study
measure: Local tissue water percentage
timeFrame: baseline of study
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Medipol University- Hacettepe University
Study officials:
References:
citation: Uhl JF, Chahim M, Allaert FA. Static foot disorders: a major risk factor for chronic venous disease? Phlebology. 2012 Feb;27(1):13-8. doi: 10.1258/phleb.2011.010060. Epub 2011 Jul 4.
citation: Forner-Cordero I, Szolnoky G, Forner-Cordero A, Kemeny L. Lipedema: an overview of its clinical manifestations, diagnosis and treatment of the disproportional fatty deposition syndrome - systematic review. Clin Obes. 2012 Jun;2(3-4):86-95. doi: 10.1111/j.1758-8111.2012.00045.x. Epub 2012 Aug 3.