Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease

NCT06238791 | Completed

• 1 other identifier: 2023 - 1151
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Insufficiency; Lipedema

Keywords

Foot deformity; venous insufficiency; pressure; Lipedema

Outcome Measures

Primary Outcomes (2)

• The presence of foot deformity

  The presence of foot deformity including hallux valgus, hallux limitus or rigidus, pes planus, pes cavus, toe deformities will be evaluated by inspection. In the presence of hallux valgus, its stage will be evaluated by measuring the angle using a universal goniometer, and in the presence of pes planus, the severity of pes planus will be determined by performing the navicular drop test.

  baseline of study

• Plantar pressure distribution

  Plantar pressure distribution (PPD) will be evaluated with EsCoSCAN® (EsCo Orthopädie Service GmbH, Germany) pedobarography. The plantar pressure in both feet will be evaluated with the force platform while standing, and the average pressure distribution percentage for each foot will be recorded.

  baseline of study

Secondary Outcomes (3)

• Ankle range of motion

  baseline of study

• Foot posture

  baseline of study

• Local tissue water percentage

  baseline of study

Study Arms (2)

Chronic venous disease group

Other: Presence of foot deformity, ankle range of motion, foot posture, local tissue water percentage, and foot pressure distribution will be evaluated in patients with chronic venous disease.

Chronic venous disease and lipedema group

Other: Presence of foot deformity, ankle range of motion, foot posture, local tissue water percentage, and foot pressure distribution will be evaluated in patients with chronic venous disease.

Interventions

Presence of foot deformity, ankle range of motion, foot posture, local tissue water percentage, and foot pressure distribution will be evaluated in patients with chronic venous disease. OTHER

Presence of foot deformity, ankle range of motion, foot posture, local tissue water percentage, and foot pressure distribution will be evaluated in patients with chronic venous disease and lipedema.

Chronic venous disease and lipedema group; Chronic venous disease group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients were divided into two groups: Patients with only CVD and patients with CVD accompanied lipedema.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Ankara Medipol University- Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 21727156 RESULT

• 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.

  PMID: 25586162 RESULT

MeSH Terms

Conditions

Lipedema; Foot Deformities; Venous Insufficiency

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 2, 2024
• Study Start: October 5, 2023
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)