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

NCT07603531 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-06-01

No results posted yet for this 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.

Conditions

  • Lymphedema Lower Extremity

Interventions

DEVICE

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).

DEVICE

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).

Sponsors & Collaborators

  • Jean-Paul Belgrado

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-06-30
Completion
2027-09-30

Countries

  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07603531 on ClinicalTrials.gov