NCT01864044

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

May 13, 2013

Last Update Submit

November 21, 2023

Conditions

Lymphoedema

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in affected limb volume

    According to the site, the first phase can lasts 1, 2 or 3 weeks.

    At the end of 1st phase of Complex Decongestive Therapy and 6 months later

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 29, 2013

Study Start

September 1, 2009

Primary Completion

March 1, 2011

Study Completion

December 1, 2012

Last Updated

November 22, 2023

Record last verified: 2023-11