- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07240324
The Effect of LymphaTouch® and Manual Lymphatic Drainage on Extremity Circumference Measurements in Lymphedema
November 16, 2025 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
The Effect of LymphaTouch® and Manual Lymphatic Drainage on Extremity Circumference Measurements in Lymphedema: A Retrospective Study
This retrospective study will be conducted using the medical records of lymphedema patients followed in the Physical Medicine and Rehabilitation outpatient clinics and lymphedema unit of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital.
Women and men aged 18-75 years with a diagnosis of upper or lower extremity lymphedema will be included.
Sociodemographic and clinical data of the patients will be recorded, and participants will be divided into two treatment groups: those who received LymphaTouch® therapy and those who underwent Manual Lymphatic Drainage (MLD).
Pre- and post-treatment extremity circumference measurements will be obtained from patient records, and the differences between the groups will be compared.
Study Overview
Study Type
Observational
Enrollment (Actual)
172
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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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
N/A
Sampling Method
Probability Sample
Study Population
ChatGPT:
The study population consists of patients with lymphedema who received either LymphaTouch® or Manual Lymphatic Drainage (MLD) treatment.
Description
Inclusion Criteria:
- Clinically diagnosed with lymphedema
- Aged between 18 and 75 years
- Complete pre- and post-treatment extremity circumference measurements available in patient records
Exclusion Criteria:
- History of systemic diseases such as diabetes, rheumatologic disorders, or malignancy
- Presence of neurological disorders (e.g., polyneuropathy, multiple sclerosis, history of stroke)
- Pregnancy
- History of surgery or major trauma involving the affected limb within the past 6 months
- History of injection therapy or physical therapy applied to the same limb within the past 6 months
- History of infection or active dermatological disease affecting the limb
- Incomplete or inconsistent data in patient records
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 |
|---|---|
|
MLD group
Patients with lympedema who received MLD treatment
|
No intervention
|
|
Lymphatouch group
Patients with lympedema who received Lymphatouch treatment
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No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Extremity Circumference (cm):
Time Frame: Baseline
|
he primary outcome will be the difference in limb circumference measurements before and after treatment.
Circumference values will be obtained from standardized anatomical landmarks, including the wrist/ankle, and at 10 cm, 20 cm, 30 cm, and 40 cm proximal to the metatarsophalangeal (MTP) or metacarpophalangeal (MCP) joint.
A greater reduction in circumference indicates a more effective treatment response.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 10, 2025
Primary Completion (Actual)
October 10, 2025
Study Completion (Actual)
November 10, 2025
Study Registration Dates
First Submitted
November 16, 2025
First Submitted That Met QC Criteria
November 16, 2025
First Posted (Actual)
November 20, 2025
Study Record Updates
Last Update Posted (Actual)
November 20, 2025
Last Update Submitted That Met QC Criteria
November 16, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- istftreah2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.