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OpenTrials
Completed

NCT Number: NCT02234674

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

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.

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Key information

Conditions

Primary Lower Limb Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Secondary Lower Limb Lymphedema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHIC Des Andaines

La Ferté-Macé, 61600, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Current intensive CDP

Other

Standard Intensive CDP including

  • manual lymph drainage,
  • pressotherapy and
  • bandaging

intensive CDP where Stendo pulsating suit replaces pressotherapy

Other

The intervention consist to perform daily during 5 days an intensive CDP where pressotheray is replaced by Stndo pulsating suit sessions.

Primary outcomes

  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 outcomes

  1. Quality of Life

    Time frame: baseline ; after 5 days intensive CDP

    36 health survey questionnaire (SF-36) and Visual Analogical Scale

Sponsors and collaborators

Lead sponsor

Stendo

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 9, 2014
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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