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

Stendo

Status: Completed

Conditions: Primary Lower Limb Lymphedema; Secondary Lower Limb Lymphedema

Treatments: Other: intensive CDP where Stendo pulsating suit replaces pressotherapy; Other: Current intensive CDP

Study type: Interventional

Funder types: Industry

Identifiers

NCT02234674

2014-A00355-42

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Standard intensive CDP

Active Comparator group

Description:

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

Treatment:

Other: Current intensive CDP

Stendo group

Experimental group

Description:

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.

Treatment:

Other: intensive CDP where Stendo pulsating suit replaces pressotherapy