Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema

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

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-02-28

Brief Summary

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This study aims at evaluating the efficacy of the Stendo pulsating suit in patients with a leg lymphedema hospitalized for intensive Complex Decongestive Physiotherapy (CDP).

This study is a pilot controlled randomized study with two arms.

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Detailed Description

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Conditions

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Primary Lower Limb Lymphedema Secondary Lower Limb Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard intensive CDP

This arm is the controlled group ; patients in that group will undergo a current practice performed in the lymphology unit.

Group Type ACTIVE_COMPARATOR

Current intensive CDP

Intervention Type OTHER

Standard Intensive CDP including

* manual lymph drainage,
* pressotherapy and
* bandaging

Stendo group

This arm contitutes the group where the Stendo pulsating suit sessions are investigated in the frame of the CDP in replacement of the pressotherapy sessions.

Group Type EXPERIMENTAL

intensive CDP where Stendo pulsating suit replaces pressotherapy

Intervention Type OTHER

The intervention consist to perform daily during 5 days an intensive CDP where pressotheray is replaced by Stndo pulsating suit sessions.

Interventions

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Current intensive CDP

Standard Intensive CDP including

* manual lymph drainage,
* pressotherapy and
* bandaging

Intervention Type OTHER

intensive CDP where Stendo pulsating suit replaces pressotherapy

The intervention consist to perform daily during 5 days an intensive CDP where pressotheray is replaced by Stndo pulsating suit sessions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient with a primary or secondary lympedema clinically diagnosed (Stemmer Sign) of one or two legs.
* Patient with a lympedema stage II (persistent) or III according to the classification of the International Society of Lymphoedema (ISL)
* Patient aged 18 or more

Exclusion Criteria

* Patient with a severe heart, kidney or liver failure,
* Patient with an advanced obstructive arterial disease
* Patient with a recent and progressive deep venous thrombosis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No