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.
Age range
18 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change of edema volume during the intensive treatment phase and maintenance phase.
Timeframe: Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).
Number of days to obtain non-pitting state (with pitting test) during intensive phase
Timeframe: Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).
Change of water content in tissue (with TDC/PWC) during the intensive treatment phase and maintenance phase.
Timeframe: Baseline (pre-intervention)/end of the intervention (intensive treatment) phase/ 1 month after the end of the intervention phase/ 6 months after the end of the intervention phase/ and 12 months after the end of the intervention phase (study completion).