Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT05483569
Eligibility Criteria:
Inclusion Criteria:
* Women between the ages of 25-65
* Having unilateral lower extremity lymphedema (including/not including the trunk) due to gynecological cancer diagnosis and treatment method.
* Having Stage 1 and 2 lymphedema according to the International Society of Lymphology (ISL) classification
* Having situation that prevents the application of manual lymph drainage (cardiac edema, acute deep vein thrombus, acute renal failure, acute pulmonary edema, etc.)
* Having a condition that prevents pressure application (arterial insufficiency, pressure intolerance, etc.)
* Not having received conservative treatment for lymphedema for at least 6 months
Exclusion Criteria:
* Having history of metastases
* Having radiogenic fibrosis in the abdomino-pelvic region
* Having additional orthopedic (scoliosis, etc.), neurological (multiple sclerosis, stroke, etc.) and rheumatological diseases (ankylosing spondylitis, rheumatoid arthritis, etc.) that will affect lower extremity functions
* Having connective tissue disease that will affect tissue properties
* Having diseases (cardiac edema, peripheral artery disease, etc.) that prevent MLD and/or bandage application
* Continuation of Radiotherapy (Must have ended at least 3 months ago) and Chemotherapy applications
* Using sedatives and/or muscle relaxants that may alter muscle tone.
* Having any surgical intervention for lymphedema
* Being diagnosed with obesity (BMI\>30)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT05483569
Study Brief:
Protocol Section:
NCT05483569