Effectiveness of BoostEd COMpression for the treatment of lower limb chronic Edema (BECOME): a pragmatic multi-centric randomized trial

Summary

The BeCOMe trial focusses on the treatment of patients with chonic edema by means of boosted compression. Boosted compression is the application of compression bandages 3 times/day.

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.

Outcomes:
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.

Theme(s): Edema, Treatment