LVA on Serum Profiling in Patients With Lymphedema

The correlation between oxidative stress and increased lymphedematous limb volume lacks supporting evidence. Lymphedema patients are prone to cellulitis. This study aims to investigate the link between oxidative stress, limb volume, and cellulitis after supermicrosurgical lymphaticovenous anastomosis (LVA).

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

About this study

In this study, we focused on the changes in serum antioxidant biomarkers before and after LVA, detected by isobaric tags for relative and absolute quantitation (iTRAQ)-based quantitative proteomic analysis, enzyme-linked immunosorbent assay (ELISA), and Oxidative Stress Panel Kit. For clinical correlation, magnetic resonance (MR) volumetry was implemented for precise lymphedematous limb volume measurements. Correlations were made between changes in oxidative stress, limb volume, and cellulitis before and after LVA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with lower limb lymphedema confirmed with lymphoscintigraphy
unilateral lower limb lymphedema
lymphedema duration > 2 years
no active infection
no prophylactic antibiotic use for at least one month before LVA
no tumor recurrence or metastasis
no consumption of antioxidants, such as vitamin E or ascorbic acid

Exclusion criteria

Patients with upper limb and bilateral lower limb lymphedema

Treatment and study plan

pre-LVA

Other

Venous serum samples were collected from patients before LVA.

post-LVA

Other

Venous serum samples were collected from patients one-month after LVA.

Primary outcomes

the correlation between post-LVA volume reduction

Time frame: 6 months after surgery

The primary outcome was determined whether post-LVA volume reduction < 40%

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

The Impact of Lymphaticovenous Anastomosis on Serum Profiling in Patients With Lymphedema

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Sep 17, 2020
Registry last updated: Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed