Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Prospective Observational Lymphoedema Intensive Treatment (POLIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01864044
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : May 29, 2013
Sponsor:
Information provided by (Responsible Party):
Thuasne

Brief Summary:

The aim of this observational study was to describe usual practices in lymphedema management in France.

It was the opportunity to assess the effects of these practices on lymphedema volume in a large number of patients, to identify predictive factors of response, and to assess the safety of this therapy.


Condition or disease
Lymphoedema

Detailed Description:

Lymphoedema is commonly treated according a strategy called Complex Decongestive Therapy (CDT). This CDT is usually composed of 2 different treatment phases. The first phase is an acute phase which aim is to reduce affected limb volume. The second phase is a maintenance phase which aim is to maintain as long as possible the volume reduction acheived during the first phase.

These 2 phases required multi modal parameters such as bandages, lymphatic drainages, physical exercises...and can be managed very differently from one site to another.

Layout table for study information
Study Type : Observational
Actual Enrollment : 306 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2009
Actual Primary Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema




Primary Outcome Measures :
  1. Change from baseline in affected limb volume [ Time Frame: At the end of 1st phase of Complex Decongestive Therapy and 6 months later ]
    According to the site, the first phase can lasts 1, 2 or 3 weeks.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consecutive adult patients hospitalized with a clinical diagnosis of unilateral stage II-III upper or lower limb lymphoedema of any etiology and an indication for intensive decongestive therapy (IDT) were enrolled.
Criteria

Inclusion Criteria:

  • consecutive adult patients
  • hospitalized with a clinical diagnosis of unilateral stage II-III upper or lower limb lymphoedema of any etiology
  • indication for intensive decongestive therapy (IDT)

Exclusion Criteria:

  • bilateral lymphedema,
  • lymphedema of both upper and lower limbs,
  • intensive decongestive therapy in the previous 6 months,
  • cancer recurrence,
  • systolic pressure index < 0.5

Layout table for additonal information
Responsible Party: Thuasne
ClinicalTrials.gov Identifier: NCT01864044    
Other Study ID Numbers: EC07
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphedema
Lymphatic Diseases