Primary Lower Limb Lymphedema, Secondary Lower Limb Lymphedema
Conditions
Keywords
Pulsating suit, lymphedema, leg volume
Brief summary
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.
Interventions
OTHERCurrent intensive CDP
Standard Intensive CDP including * manual lymph drainage, * pressotherapy and * bandaging
OTHERintensive 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.
Sponsors
Stendo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| volume of the most affected leg | baseline ; after 5 days intensive CDP | Change in % of the volume of the most affected leg according to disk model method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | baseline ; after 5 days intensive CDP | 36 health survey questionnaire (SF-36) and Visual Analogical Scale |
Countries
France
Outcome results
None listed