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

NCT07603531 | Not Yet Recruiting DMC

• 3 other identifiers: DDS2 V1.3_11052026CIV-25-10-054914ID-RCB: 2025-A0810-49
• Study Type: interventional
• Target: 98
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

Complex decongestive therapy; Dynamic compression; Non-inferiority trial; Lymphoedema maintenance treatment; Limb volume reduction; Limb volume maintenance

Outcome Measures

Primary Outcomes (1)

• Relative excess limb volume (%)

  Change in relative excess limb volume (%) of the affected limb from baseline (Day 0) to the end of the 12-week maintenance phase treatment, based on circumferential tape measurements.

  12 weeks

Secondary Outcomes (20)

• Longitudinal change in excess volume of the affected limb in ml

  12 weeks

• Longitudinal change in the volume of the feet in ml

  12 weeks

• Dermal and subcutaneous tissue thickness in mm

  12 weeks

• Compressibility of the skin and subcutaneous tissue in mm

  12 weeks

• Viscoelasticity of the skin and subcutaneous tissue complex

  12 weeks

Other Outcomes (4)

• Safety outcome: Number of participants with adverse events and device-related safety issues over 12 weeks

  12 weeks

• Exploratory objectives: Assess the coherence between three volumetric methods

  12 weeks

• Exploratory coherence between methods of assessing skin and subcutaneous tissue thickness

  12 weeks

Study Arms (2)

Control group: Currently available compression devices

ACTIVE COMPARATOR

Control group: Currently available compression devices Patients in the control group will structure the maintenance phase treatment of their lower limb lymphoedema depending on personal preferences and the recommendations of their treating physician(s).

Device: Control group: Currently available compression devices

DDS group: Dynamic compression device (DDS)

EXPERIMENTAL

Patients in the DDS group will structure the maintenance phase of thier lower limb lymphodema treatment depending on their personal preferences and the recommendations of their treating physician(s).

Device: DDS group: Dynamic compression device (DDS)

Interventions

Control group: Currently available compression devices DEVICE

Participant in the control group may use all currently available compression devices to treat their lymphoedema, in addition to the prescribed elastic garment(s).

Control group: Currently available compression devices

DDS group: Dynamic compression device (DDS) DEVICE

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).

DDS group: Dynamic compression device (DDS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Jean-Paul Belgrado: lead

Study Sites (3)

CHU Montpellier - Saint Eloi

Montpellier, 34090, France

Location

CHU Toulouse - Rangueil

Toulouse, 31059, France

Location

Lympho-Opt Fachklinik fur Lymphologie

Pommelsbrunn, Bavaria, 91224, Germany

Location

Central Study Contacts

Prof. Jean-Paul Belgrado, PhD

CONTACT

+33 6 38 39 79 56; jp.belgrado@gmail.com

Velika V Stoitchkova, MSc

CONTACT

+359 882 40 55 33; velika.stoichkova@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Coordinator of the Lymphology and Rehabilitation Research Unit, Université libre de Bruxelles (ULB)

Model Details: Prospective, multi-center, interventional, pre-market, pivotal, confirmatory, assessor-blinded study, randomized clinical trial

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

DE (1); FR (2)