Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema

Lymphedema Clinical Trial

Official title:

The Role of Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237907
• Other study ID #: 202201327B0
• Status: Recruiting
• Start date: September 20, 2023
• Est. completion date: January 12, 2026

Study information

• Verified date: September 2023
• Source: Chang Gung Memorial Hospital
• Contact: Ching-Hua Hsieh, PhD
• Phone: +886-7-7317123
• Email: m93chinghua[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 12, 2026
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema

Intervention

Other:
• Patients underwent lymphedema surgery
Patients who have developed lymphedema and undergone lymphedema surgery.
• 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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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