About this trial
The goal of this study is to compare the efficacy of a dynamic compression device (DDS) with traditional multicomponent bandages (TMCB) in terms of excess volume reduction in lower limb lymphoedema during the first 5 days of intensive treatment.
Participants in both groups will undergo the standard decongestive treatment protocol of the trial site. The only difference between both groups will be the modality of the compression therapy:
* the intervention (DDS) group will wear the compression 24/24 during the first 5 days of intensive treatment * the control group will wear TMCB 24/24 during the first 5 days of intensive treatment (i.e. the standard treatment)
Eligibility criteria
Qualifiers
Age ≥ 18 years
Men and women
Unilateral lower limb lymphoedema of stage II or III according to the criteria defined by the International Society of Lymphology
Relative volume difference between affected and healthy leg ≥ 10%
Disqualifiers
Patients with suspended lymphoedema of the thigh (unaffected calf and foot)
Patients with lipedema
Patients with bilateral lower limb lymphoedema
Patients with a lymphoedema associated with active cancer requiring acute chemotherapy, or oncologic relapses, or treatment in progress
Trial design
Treatments tested in this trial
- Control group: Traditional multicomponent bandages
- DDS group: Dynamic compression device (DDS)
Treatment groups
Sponsors and collaborators
Jean-Paul Belgrado
Lead sponsor
Université Libre de Bruxelles
Sponsor institution