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

NCT07622615 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-06-03

No results posted yet for this study

Summary

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)

Conditions

  • Lymphedema Lower Extremity

Interventions

DEVICE

Control group: Traditional multicomponent bandages

In the control group, patients will wear traditional multicomponent bandages as a compression therapy modality 24/24 during the first 5 days of intensive treatment

DEVICE

DDS group: Dynamic compression device (DDS)

Patients in the DDS group will wera the inverventional dynamic compression device as a compression modality 24/24 during the first five days of inpatient intensive treatment.

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
2027-12-30

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 NCT07622615 on ClinicalTrials.gov