Assessment of the Efficacy of the Dynamic Decongestive System in the Intensive Phase of Lower Limb Lymphedema

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJean-Paul Belgrado

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

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Jean-Paul Belgrado

Lead sponsor

Université Libre de Bruxelles

Sponsor institution