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

Chronic Venous Insufficiency Clinical Trial

Official title:

Static Plantar Pressure Distribution and Presence of Foot Deformities in Patients With Lipedema and Chronic Venous Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06238791
• Other study ID #: 2023 - 1151
• Status: Completed
• Start date: October 5, 2023
• Est. completion date: January 24, 2024

Study information

• Verified date: January 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 24, 2024
• Est. primary completion date: January 24, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Foot Deformities
• Lipedema
• Venous Insufficiency

Intervention

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.
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.

Locations

Country	Name	City	State
Turkey	Ankara Medipol University- Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Ankle range of motion	Ankle dorsi- and plantar-flexion range of motion will be measured using a universal goniometer.	baseline of study
Secondary	Foot posture	The foot posture will be evaluated with the Foot Posture Index.	baseline of study
Secondary	Local tissue water percentage	Local tissue water percentages will be evaluated with the Moisturemeter-d compact (MMDc, Delfin Technologies, Kuopio, Finland) device.	baseline of study