Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 4, 2014
CompletedFirst Posted
Study publicly available on registry
September 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMay 22, 2015
September 1, 2014
5 months
September 4, 2014
May 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
volume of the most affected leg
Change in % of the volume of the most affected leg according to disk model method
baseline ; after 5 days intensive CDP
Secondary Outcomes (1)
Quality of Life
baseline ; after 5 days intensive CDP
Study Arms (2)
Standard intensive CDP
ACTIVE COMPARATORThis arm is the controlled group ; patients in that group will undergo a current practice performed in the lymphology unit.
Stendo group
EXPERIMENTALThis arm contitutes the group where the Stendo pulsating suit sessions are investigated in the frame of the CDP in replacement of the pressotherapy sessions.
Interventions
Standard Intensive CDP including * manual lymph drainage, * pressotherapy and * bandaging
The intervention consist to perform daily during 5 days an intensive CDP where pressotheray is replaced by Stndo pulsating suit sessions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stendolead
Study Sites (1)
CHIC Des Andaines
La Ferté-Macé, 61600, France
Related Publications (2)
Deltombe T, Jamart J, Recloux S, Legrand C, Vandenbroeck N, Theys S, Hanson P. Reliability and limits of agreement of circumferential, water displacement, and optoelectronic volumetry in the measurement of upper limb lymphedema. Lymphology. 2007 Mar;40(1):26-34.
PMID: 17539462RESULTMayrovitz HN, Macdonald J, Davey S, Olson K, Washington E. Measurement decisions for clinical assessment of limb volume changes in patients with bilateral and unilateral limb edema. Phys Ther. 2007 Oct;87(10):1362-8. doi: 10.2522/ptj.20060382. Epub 2007 Aug 7.
PMID: 17684090RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2014
First Posted
September 9, 2014
Study Start
September 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
May 22, 2015
Record last verified: 2014-09