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Boosted Compression for Lower Limb Chronic Edema
Sponsor: Universiteit Antwerpen
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.
Official title: Effectiveness of BoostEd COMpresson for the Treatment of Lower Limb Chronic Edema (BECOME): a Pragmatic Multi-centric Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-06
Completion Date
2029-12-31
Last Updated
2026-07-16
Healthy Volunteers
No
Conditions
Interventions
Conservative edema treatment (complex decongestive therapy)
Conservative decongestive edema treatment with a single application of the compression bandage/day.
Conservative 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