NCT04552938

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
Last Updated

September 17, 2020

Status Verified

April 1, 2018

Enrollment Period

2.1 years

First QC Date

September 14, 2020

Last Update Submit

September 16, 2020

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

  • the correlation between post-LVA volume reduction

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

    6 months after surgery

Study Arms (1)

Patients underwent supermicrosurgical LVA

Patients underwent supermicrosurgical LVA between June 2018 and May 2019.

Other: pre-LVAOther: post-LVA

Interventions

pre-LVAOTHER

Venous serum samples were collected from patients before LVA.

Patients underwent supermicrosurgical LVA
post-LVAOTHER

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

Patients underwent supermicrosurgical LVA

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Written informed consent was obtained from all patients. Between June 2018 and May 2019, 26 patients with lower limb lymphedema confirmed with lymphoscintigraphy were recruited. Patients with upper limb and bilateral lower limb lymphedema were excluded.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with upper limb and bilateral lower limb lymphedema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 17, 2020

Study Start

April 11, 2018

Primary Completion

June 1, 2020

Study Completion

September 11, 2020

Last Updated

September 17, 2020

Record last verified: 2018-04

Locations

TW(1)