RecruitingNot ApplicableNCT07708662

Boosted Compression for Lower Limb Chronic Edema

Effectiveness of BoostEd COMpresson for the Treatment of Lower Limb Chronic Edema (BECOME): a Pragmatic Multi-centric Randomized Trial


Sponsor

Universiteit Antwerpen

Enrollment

160 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Patients: Patients targeted in this proposal comprise individuals afflicted by chronic edema/lymphedema of the lower limbs. Intervention: The intervention entails the incorporation of boosted compression alongside standard care during the intensive treatment phase. Boosted compression involves thrice-daily re-application of a multicomponent short stretch compression bandage, aimed at enhancing the efficacy of compression therapy within edema treatment. Comparison: Comparison will be made between the experimental intervention (boosted compression) and the prevailing standard edema treatment, which adheres to the complex decongestive therapy as stipulated by healthcare services, utilizing a single daily application of compression bandage. Standard care is administered under the supervision of trained physical therapists, specialized in edema treatment. Outcome: Primary outcomes encompass the determination of: 1. the requisite number of treatment days to attain a non-pitting edema state during the intensive phase of edema treatment; and 2. the non-inferiority of boosted compression in maintaining reduced edema volume during the maintenance phase assessed at 1y of follow-up. Secondary outcomes encompass assessments of: Quality of Life, acceptance, and adherence to boosted compression, alongside evaluations of time and cost-effectiveness associated with its implementation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Conservative edema treatment (complex decongestive therapy) and Conservative edema treatment with boosted compression therapy for people with chronic edema and lymphedema. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERConservative edema treatment (complex decongestive therapy)

Conservative decongestive edema treatment with a single application of the compression bandage/day.

OTHERConservative edema treatment with boosted compression therapy

Conservative edema treatment with boosted compression therapy (3 applications/day of the compression bandage)


Locations(4)

Antwerp University Hospital

Edegem, Antwerp, Belgium

University of Antwerp

Wilrijk, Antwerp, Belgium

University Hospital Leuven

Leuven, Brabant, Belgium

Ghent University Hospital

Ghent, East Flanders, Belgium

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NCT07708662


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