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

Official title

A Multicenter Controlled Randomised Clinical Trial to Assess the Efficacy of the Dynamic Decongestive System During the Maintenance Phase of Lower Limb Lymphedema Treatment

Overview

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.

Detailed description

Background:

Lymphedema is a chronic, progressive condition characterized by impaired lymphatic drainage, leading to the accumulation of protein-rich fluid in the interstitial tissues, progressive tissue remodeling, and an increased risk of complications such as infection. Although lymphedema is not curable, standard management combining intensive decongestive therapy followed by lifelong maintenance treatment can significantly reduce limb volume, improve function, and enhance quality of life. However, maintaining long-term disease control remains challenging.

The maintenance phase relies primarily on compression therapy and patient self-management. Adherence is often suboptimal due to treatment complexity, cost, limited access to specialized care, and the impact of therapy on daily activities. As a result, patients frequently experience recurrent edema, functional impairment, and infectious complications such as cellulitis, contributing to a substantial clinical and socioeconomic burden.

Current standard approaches, including multicomponent bandaging and elastic compression garments, are effective but have important limitations. Multicomponent bandaging is highly operator-dependent, time-consuming, and difficult to maintain because frequent adjustments are required as limb volume changes. Elastic compression garments, while more practical, may be insufficient to achieve sustained decongestion, particularly in patients with moderate-to-severe disease. Overall, existing therapies often fail to provide consistent long-term edema control in real-world settings.

Recent technological advances have enabled the development of dynamic compression systems designed to improve usability and treatment consistency.

The Dynamic Decongestion System (DDS) is designed to standardize compression delivery, reduce operator dependency, and support patient autonomy in the home setting. This study aims to evaluate the clinical relevance of DDS as an adjunct to standard maintenance therapy in patients with primary or secondary lymphedema who have completed intensive decongestive treatment, with the objective of improving long-term volume control and reducing the overall burden of disease.

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).

Primary outcome measures

• Relative excess limb volume (%) [Time frame: 12 weeks]

Secondary outcome measures (12)

• Longitudinal change in excess volume of the affected limb in ml [Time frame: 12 weeks]
• Longitudinal change in the volume of the feet in ml [Time frame: 12 weeks]
• Dermal and subcutaneous tissue thickness in mm [Time frame: 12 weeks]
• Compressibility of the skin and subcutaneous tissue in mm [Time frame: 12 weeks]
• Viscoelasticity of the skin and subcutaneous tissue complex [Time frame: 12 weeks]
• Skin temperature of the affected limb (in C°) [Time frame: 12 weeks]
• Lower limb contour changes [Time frame: 12 weeks]
• Depth of the pitting sign in mm [Time frame: 12 weeks]
• Incremental cost-effectiveness ratio (ICER) of DDS versus CATP [Time frame: 12 weeks]
• Frequency of infectious episodes [Time frame: 12 weeks]
• Patient-reported quality of life [Time frame: 12 weeks]
• Patient's observance to compression therapy [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years
• Men and women
• Unilateral lower limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology
• Patients completing an inpatient intensive treatment phase, including patients participating in CIV-25-01-050914, with a minimum of 20% of excess volume reduction
• Patients who have given their informed consent freely and signed it prior to any intervention in the study.
• Patients with a morphology compatible with the perimetric coverage of the device (calf and thigh).
• Patients able to use the device
• Patients enrolled in a social security plan or covered by similar health insurance.

Exclusion criteria

• Patients with suspended lymphoedema of the thigh (unaffected calf and foot)
• Patients with lipedema
• Patients with bilateral lower limb lymphoedema
• Patients with a lymphedema associated with active cancer requiring acute chemotherapy, or oncologic relapses, or treatment in progress
• Patients with contraindications for compression on the lower limbs such as stent/arterial graft in the area under compression
• Peripheral artery disease ABI ≤ 0.6
• Advanced diabetic microangiopathy
• Active deep/superficial active or recent venous thrombosis, phlegmasia ceruela dolens (painful blue inflammation), active venous leg ulcers, septic/acute thrombophlebitis of the limb (in the last 6 months)
• A condition where increased venous or lymphatic return is undesirable
• Neurological disease (including neurogenic diabetic foot, severe peripheral neuropathy of the limb)
• Pulmonary embolism (last 6 months), pulmonary edema, poorly controlled asthma
• Cardiac insufficiency (compensated or decompensated)
• Implantable stimulation devices such as pacemaker
• Chronic kidney disease with acute renal failure
• Open skin lesions or skin and subcutaneous infection (cellulitis, erysipelas, lymphangitis, etc.)
• Skin atrophy of the limb
• Bullous dermatoses
• Presence of subcutaneous osteosynthesis material with an external component lying subdermally at the level of the treated lower limb
• Hyperalgesia of the foot, knee or hip
• Patients with a known allergy to the components used in the device
• Patients with psychiatric, psychological, or neurological disorders
• Patients with impaired cognitive or motor skills and dependent individuals
• Patients participating in another clinical trial
• Pregnant or breastfeeding women. Women of childbearing potential will undergo Clearblue® urine pregnancy testing prior to enrollment to verify eligibility.
• Vulnerable patients, adults being the object of a legal protective measure or unable to express their consent
• Patients unable to submit to the constraints of the protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

France · 2 centers

• CHU Montpellier - Saint Eloi — Montpellier
• CHU Toulouse - Rangueil — Toulouse

Germany · 1 center

• Lympho-Opt Fachklinik fur Lymphologie — Pommelsbrunn

Identifiers

NCT: NCT07603531 · DDS2 V1.3_11052026 · CIV-25-10-054914 · ID-RCB: 2025-A0810-49

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗