Boosted compression for lower limb edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pragmatic interventional study compares boosted compression added to standard complex decongestive therapy (CDT) against CDT alone for lower-limb chronic edema. The boosted approach uses three daily applications of a short-stretch bandage during an intensive treatment phase, delivered by patients or care providers under therapist supervision. Primary outcomes include days to reach a non-pitting state, edema volume by circumference, and tissue water content at the start and end of the intensive phase. A secondary aim is to determine whether any edema reduction is maintained during the subsequent maintenance phase, in a non-inferiority framework. Real-world clinical settings and multiple European centers are involved to reflect routine practice.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Patients suffering from chronic edema ( \> 3 months) of the lower extremity with a positive pitting sign and a conservative treatment is prescribed.

  -≥ 18 years old
* BMI is \<36
* Able to understand and follow instructions in Dutch

Exclusion criteria:

* All treatable causes of chronic edema, such as hormonal disturbances (e.g. thyroid dysfunction), protein abnormalities (especially Albumin), cardiac insufficiency, nephrological conditions, drug-induced edema or peripheral arterial disease.
* Peripheral arterial disease (ABI \< 0.55)
* The patient is allergic for one of the products we use during the treatment, and no alternative is available
* The patient has wounds at the level of the treated edema zone.
* The patient is currently receiving treatment within the convention "lymfoedeem" according to the Belgian Health insurance (RIZIV-INAMI).
* The patient is not able to give written consent.

Where it's running

• Antwerp University Hospital
  Edegem, Antwerp, Belgium Recruiting
• University of Antwerp
  Wilrijk, Antwerp, Belgium Recruiting
• University Hospital Leuven
  Leuven, Brabant, Belgium Recruiting
• Ghent University Hospital
  Ghent, East Flanders, Belgium Recruiting

Study contacts

• Study coordinator: Nick Gebruers, PT, PhD, Professor
• Email: nick.gebruers@uantwerpen.be
• Phone: +32496184346

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.