Prospective Observational Lymphoedema Intensive Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

306 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphoedema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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EC07

Identifier Type: -

Identifier Source: org_study_id