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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 2026-05-22

No results posted yet for this study

Summary

The trial aims to compare the dynamic compression device in combination with elastic compression garments is non-inferior to all currently available compression devices (CACD) during the maintenance phase of lower limb lymphoedema treatment.

The trial involves 2 parallel groups. Both groups will include patients who are being discharged from the inpatient intensive treatment phase for lower limb lymphoedema. Eligible participants will be enrolled in the study on the afternoon of their last inpatient treatment day, prior to discharge.

DDS group: elastic compression garment at least during the day and as often as possible during the night (depending on personal preferences and expert advice) + DDS for a minimum of 2h at the end of the day (alone without an elastic garment).

Control group: elastic compression garment at least during the day and as often as possible during the night (depending on personal preferences and expert advice) + all currently available compression devices (CACD), including multicomponent bandages, pneumatic compression devices, and compression wraps, depending on patient preference and the center's recommendations.

Manual lymphatic drainage will be acceptable for both groups.

Patients will be assessed during three measurement sessions:

Visit 1 / baseline-inclusion (V1) - on the afternoon of their last inpatient treatment day, prior to discharge from intensive treatment, Visit 2 (V2) - at the end of week 6 (± 7 days) Visit 3 (V3) - at the 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