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
Universiteit Antwerpen
160 participants
Jun 1, 2026
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
Inclusion Criteria4
- 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 Criteria6
- 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.
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Interventions
Conservative decongestive edema treatment with a single application of the compression bandage/day.
Conservative edema treatment with boosted compression therapy (3 applications/day of the compression bandage)
Locations(4)
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NCT07708662