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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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).
• Устройство 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).

Первичные конечные точки

• Relative excess limb volume (%) [Срок оценки: 12 weeks]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

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

Германия · 1 центр

• Lympho-Opt Fachklinik fur Lymphologie — Pommelsbrunn

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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