Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema
Condition(s) studied
Investigational drug(s) / intervention(s)
Control group: Currently available compression devices: Participant in the control group may use all currently available compression devices to treat their lymphoedema, in addition to the prescribed elastic garment(s).
DDS group: Dynamic compression device (DDS): Patients in the DDS group are limited to using the DDS device for a minimum of 2h at the end of the day as an adjuvant compression modality to the prescribed elastic garment(s).
Study summary
The trial aims to determine whether the dynamic compression device, used in combination with elastic compression garments, is non-inferior to currently available compression devices (CACD) during the maintenance phase of lower-limb lymphoedema treatment.
This is a two-arm, parallel-group trial. Both groups will include patients being discharged after the inpatient intensive treatment phase for lower-limb lymphoedema. Eligible participants will be enrolled on the afternoon of their final inpatient treatment day, prior to discharge.
Participants will be allocated to one of the following groups:
DDS group: elastic compression garment worn at least during the day and as often as possible during the night, according to patient preference and expert advice, plus DDS use for a minimum of 2 hours at the end of the day, used alone without an elastic garment.
Control group: elastic compression garment worn at least during the day and as often as possible during the night, according to patient preference and expert advice, plus currently available compression devices, including multicomponent bandages, pneumatic compression devices, and compression wraps, according to patient preference and the center's recommendations.
Manual lymphatic drainage will be permitted in both groups.
Patients will undergo three assessment visits:
Visit 1 / Baseline-Inclusion (V1): afternoon of the final inpatient treatment day, prior to discharge from intensive treatment; Visit 2 (V2): end of week 6, ± 7 days; Visit 3 (V3): end of week 12, ± 7 days.
Eligibility
Primary outcome measure(s)
- Relative excess limb volume (%) — 12 weeks
Change in relative excess limb volume (%) of the affected limb from baseline (Day 0) to the end of the 12-week maintenance phase treatment, based on circumferential tape measurements.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Montpellier - Saint Eloi | Montpellier | France | |
| CHU Toulouse - Rangueil | Toulouse | France | |
| Lympho-Opt Fachklinik fur Lymphologie | Pommelsbrunn | Bavaria |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07603531 on ClinicalTrials.gov ↗ ← All trials in France