Prospective Observational Lymphoedema Intensive Treatment

The aim of this observational study was to describe usual practices in lymphedema management in France.

It was the opportunity to assess the effects of these practices on lymphedema volume in a large number of patients, to identify predictive factors of response, and to assess the safety of this therapy.

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Key information

Conditions

Lymphoedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Lymphoedema is commonly treated according a strategy called Complex Decongestive Therapy (CDT). This CDT is usually composed of 2 different treatment phases. The first phase is an acute phase which aim is to reduce affected limb volume. The second phase is a maintenance phase which aim is to maintain as long as possible the volume reduction acheived during the first phase.

These 2 phases required multi modal parameters such as bandages, lymphatic drainages, physical exercises...and can be managed very differently from one site to another.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

consecutive adult patients
hospitalized with a clinical diagnosis of unilateral stage II-III upper or lower limb lymphoedema of any etiology
indication for intensive decongestive therapy (IDT)

Exclusion criteria

bilateral lymphedema,
lymphedema of both upper and lower limbs,
intensive decongestive therapy in the previous 6 months,
cancer recurrence,
systolic pressure index < 0.5

Treatment and study plan

Primary outcomes

Change from baseline in affected limb volume

Time frame: At the end of 1st phase of Complex Decongestive Therapy and 6 months later

According to the site, the first phase can lasts 1, 2 or 3 weeks.

Sponsors and collaborators

Lead sponsor

Thuasne

Industry

Registry information

Acronym: POLIT

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2012
First posted: May 29, 2013
Registry last updated: Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed