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

May 21, 2015 updated by: Stendo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La FERTE MACE, France, 61600
        • CHIC Des Andaines

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline ; after 5 days intensive CDP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: baseline ; after 5 days intensive CDP
36 health survey questionnaire (SF-36) and Visual Analogical Scale
baseline ; after 5 days intensive CDP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stendo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Estimate)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00355-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Lower Limb Lymphedema

Clinical Trials on Current intensive CDP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe