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Clinical Trials in Spain / NCT06454734
Recruiting Not applicable

Shock Wave Therapy for Lower Limb Lymphedema

NCT06454734 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2024-05-28
Last updated
2025-07-31

Condition(s) studied

Lymphedema, Lower Limb

Investigational drug(s) / intervention(s)

Extracorporeal shock wave therapy by radial devicePlacebo extracorporeal shock wave therapy by radial deviceDLT

Extracorporeal shock wave therapy by radial device: Patients will receive treatment by extracorporeal shock waves therapy (ESWT).

Placebo extracorporeal shock wave therapy by radial device: Patients will receive treatment sham extracorporeal shock waves.

DLT: Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)

Study summary

This is a double-blind randomized clinical trial to compare the effect of shock wave therapy on lower limb lymphedema. There are two arms: A) complex decongestive therapy + extracorporeal shock waves therapy; B) complex decongestive therapy plus placebo extracorporeal shock waves.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria * Patients with lower limb lymphedema * Lymphedema of at least 6 months of evolution * The lymphedema must affect at least the knee to the foot * Moderate or severe lymphedema (grades 2 or 3) * Sign the informed consent Exclusion criteria * Under 18 years of age * Coagulation disorders (hemophilia, treatment with acenocoumarol, etc.) * Current or previous deep vein thrombosis of the lower extremity * Pregnancy * Electronic implantable medical devices as pacemaker implants, medication pumps, etc * Having received treatment with complex decongestive therapy or shock waves during the last 6 months * Treatment with corticosteroids or radiotherapy in the area to be treated in the last 6 weeks * Active oncological disease in the area to be treated * Active infectious-inflammatory process in the area to be treated * Cognitive or sensory deficits that prevent collaboration * Inability to walk independently or inability to attend therapy

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital del Mar Barcelona Spain Recruiting

More Parc de Salut Mar trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06454734 on ClinicalTrials.gov ↗ ← All trials in Spain