NCT06237907

Brief Summary

The project aims to compare the differences in the expression of cell death through apoptosis and iron-dependent cell death after the reduction of edema symptoms following lymphedema surgery in patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2026

Completed
Last Updated

February 2, 2024

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

January 16, 2024

Last Update Submit

January 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The correlation between post-LVA volume reduction

    The differences in expression of cell necrosis and iron-dependent cell death after lymphedema surgery were observed in patients, following alleviation of edema symptoms.

    1 month after surgery

Study Arms (1)

Patients underwent surgery

Other: Patients underwent lymphedema surgeryOther: Patients underwent surgery without LVA

Interventions

Patients who have developed lymphedema and undergone lymphedema surgery.

Patients underwent surgery

For patients who have not experienced lymphedema but require surgery due to other disease such as cancer, trauma, chronic wounds, skin defects, etc.

Patients underwent surgery

Eligibility Criteria

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

Patients as experimental group who has lymphedema and need to underwent surgery. Patients as control group who require surgery without lymphedema. Written informed consent was obtained from all patients.

You may qualify if:

  • Control Group: Patients who have not experienced lymphedema but require surgery due to other diseases such as cancer, trauma, chronic wounds, skin defects, etc.
  • Experimental Group: Patients who have lymphedema and undergone lymphedema surgery.

You may not qualify if:

  • \. Individuals with venous thrombosis, chronic heart failure, and renal failure.
  • \. Vulnerable populations, individuals with limited mobility, pregnant women, and minors.
  • \. Those expected to be unable to attend follow-up visits or complete the study smoothly.
  • \. Participants who express doubts about the trial and cannot provide satisfactory answers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

RECRUITING

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Ching-Hua Hsieh, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 16, 2024

First Posted

February 2, 2024

Study Start

September 20, 2023

Primary Completion

September 20, 2024

Study Completion

January 12, 2026

Last Updated

February 2, 2024

Record last verified: 2023-09

Locations