CompletedNot Applicable

Physical Therapies in the Decongestive Treatment of Lymphedema

Spain194 participantsStarted 2004-02

Plain-language summary

The purpose of this multicenter randomised controlled study is to determine whether manual lymphatic drainage (MLD) brings any benefit when added to intermittent pneumatic compression (IPC) plus multilayer, multicomponent bandages (MB) in the decongestive lymphatic therapy (DLT) in patients with lymphedema

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * primary or secondary lymphedema, * lymphedema stages II or III * affecting unilateral upper or lower limb * Excess volume (EV) \> 10% Exclusion Criteria: * malignancy or active neoplasm disease or lack of information about it. * active lymphangitis * known contraindications for Decongestive Lymphatic Therapy (DLT): renal insufficiency, uncontrolled hypertension, cardiac disease and venous thrombosis. * a course of DLT during last year. * anything that could alter the patient's capability to consent truly to participate in this study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage reduction in Excess Volume (PREV)

Timeframe: at 10 sessions of DLT (2 weeks), at 20 sessions of DLT (4 weeks) and at 1, 6 and 12 months after the end of DLT

Trial details

NCT IDNCT01748604

SponsorIsabel Forner-Cordero, MD, PhD.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-01

View on ClinicalTrials.gov More Primary Lymphedema trials