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RECRUITING
NCT07708662
NA

Boosted Compression for Lower Limb Chronic Edema

Sponsor: Universiteit Antwerpen

View on ClinicalTrials.gov

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

Interventions

OTHER

Conservative edema treatment (complex decongestive therapy)

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

OTHER

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