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

Stendo25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Lower Limb Lymphedema Secondary Lower Limb Lymphedema

Interventions

Current intensive CDPOTHER

Standard Intensive CDP including * manual lymph drainage, * pressotherapy and * bandaging

intensive CDP where Stendo pulsating suit replaces pressotherapyOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHIC Des Andaines

La Ferté-Macé, France

Outcomes

Primary Outcomes

volume of the most affected leg

Change in % of the volume of the most affected leg according to disk model method

Time frame: baseline ; after 5 days intensive CDP

Secondary Outcomes

Quality of Life

36 health survey questionnaire (SF-36) and Visual Analogical Scale

Time frame: baseline ; after 5 days intensive CDP

Data from ClinicalTrials.gov

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