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

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ClinicalTrials.gov Identifier: NCT02234674
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Stendo

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.


Condition or disease Intervention/treatment Phase
Primary Lower Limb Lymphedema Secondary Lower Limb Lymphedema Other: Current intensive CDP Other: intensive CDP where Stendo pulsating suit replaces pressotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Efficacy Study of the Stendo Pulsating Suit in Patient With Leg Lymphoedema
Study Start Date : September 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Active Comparator: Standard intensive CDP
This arm is the controlled group ; patients in that group will undergo a current practice performed in the lymphology unit.
Other: Current intensive CDP

Standard Intensive CDP including

  • manual lymph drainage,
  • pressotherapy and
  • bandaging

Experimental: Stendo group
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.
Other: intensive 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.




Primary Outcome Measures :
  1. volume of the most affected leg [ Time Frame: baseline ; after 5 days intensive CDP ]
    Change in % of the volume of the most affected leg according to disk model method


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: baseline ; after 5 days intensive CDP ]
    36 health survey questionnaire (SF-36) and Visual Analogical Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234674


Locations
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France
CHIC Des Andaines
La FERTE MACE, France, 61600
Sponsors and Collaborators
Stendo

Publications of Results:
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Responsible Party: Stendo
ClinicalTrials.gov Identifier: NCT02234674     History of Changes
Other Study ID Numbers: 2014-A00355-42
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: September 2014

Keywords provided by Stendo:
Pulsating suit
lymphedema
leg volume

Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases