Prospective Observational Lymphoedema Intensive Treatment

Lymphoedema Clinical Trial

— POLIT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864044
• Other study ID #: EC07
• Status: Completed
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: November 2023
• Source: Thuasne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Lymphedema
• Lymphoedema

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thuasne

Outcome

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