Lymphoedema Clinical Trial
— POLITNCT number | NCT01864044 |
Other study ID # | EC07 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2009 |
Est. completion date | December 2012 |
Verified date | November 2023 |
Source | Thuasne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 306 |
Est. completion date | December 2012 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Thuasne |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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