Back to resultsPilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema
Primary Purpose
Primary Lower Limb Lymphedema, Secondary Lower Limb Lymphedema
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Current intensive CDP
intensive CDP where Stendo pulsating suit replaces pressotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Lower Limb Lymphedema focused on measuring Pulsating suit, lymphedema, leg volume
Eligibility Criteria
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
Sites / Locations
- CHIC Des Andaines
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard intensive CDP
Stendo group
Arm Description
This arm is the controlled group ; patients in that group will undergo a current practice performed in the lymphology unit.
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.
Outcomes
Primary Outcome Measures
volume of the most affected leg
Change in % of the volume of the most affected leg according to disk model method
Secondary Outcome Measures
Quality of Life
36 health survey questionnaire (SF-36) and Visual Analogical Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02234674
Brief Title
Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema
Official Title
Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stendo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Lower Limb Lymphedema, Secondary Lower Limb Lymphedema
Keywords
Pulsating suit, lymphedema, leg volume
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard intensive CDP
Arm Type
Active Comparator
Arm Description
This arm is the controlled group ; patients in that group will undergo a current practice performed in the lymphology unit.
Arm Title
Stendo group
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Current intensive CDP
Intervention Description
Standard Intensive CDP including
manual lymph drainage,
pressotherapy and
bandaging
Intervention Type
Other
Intervention Name(s)
intensive CDP where Stendo pulsating suit replaces pressotherapy
Intervention Description
The intervention consist to perform daily during 5 days an intensive CDP where pressotheray is replaced by Stndo pulsating suit sessions.
Primary Outcome Measure Information:
Title
volume of the most affected leg
Description
Change in % of the volume of the most affected leg according to disk model method
Time Frame
baseline ; after 5 days intensive CDP
Secondary Outcome Measure Information:
Title
Quality of Life
Description
36 health survey questionnaire (SF-36) and Visual Analogical Scale
Time Frame
baseline ; after 5 days intensive CDP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHIC Des Andaines
City
La FERTE MACE
ZIP/Postal Code
61600
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17539462
Citation
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.
Results Reference
result
PubMed Identifier
17684090
Citation
Mayrovitz 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.
Results Reference
result
Learn more about this trial
Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema
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