Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema

January 24, 2024 updated by: Chang Gung Memorial Hospital

The Role of Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This project aims to investigate the expression of cell death through apoptosis and iron-dependent cell death in the subcutaneous adipose tissue of patients with lymphedema. The study also seeks to explore the roles of these processes among lymphatic endothelial cells, adipocytes, and macrophages, and their association with lymphedema, thus gaining insights into the pathophysiological mechanisms of lymphedema. Furthermore, 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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients underwent surgery
Other: Patients underwent lymphedema surgery
Patients who have developed lymphedema and undergone lymphedema surgery.
Other: Patients underwent surgery without LVA
For patients who have not experienced lymphedema but require surgery due to other disease such as cancer, trauma, chronic wounds, skin defects, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation between post-LVA volume reduction
Time Frame: 1 month after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Estimated)

September 20, 2024

Study Completion (Estimated)

January 12, 2026

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202201327B0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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