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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06237907
Other study ID # 202201327B0
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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