Lower Limb Lymphedema Treatment by Extracorporeal Shock Wave Therapy: Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Spain
Hospital del Mar
RECRUITING
Barcelona
Contact Information
Primary
Roser Belmonte, MD, PhD
rbelmonte@psmar.cat
+34 933674214
Backup
Esther Duarte, MD, PhD
eduarte@psmar.cat
+34 933674214
Time Frame
Start Date: 2024-05-28
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Experimental: DLT + ESWT
To DLT + ESWT group, decongestive lymphatic therapy (DLT) plus radial extracorporeal wave treatment (ESWT) will be applied, at a dose and intensity probed to be useful to diminish volume in upper limb lymphedema.
Sham_comparator: DLT + Sham ESWT
To DLT + Sham ESWT group, decongestive lymphatic therapy plus sham radial extracorporeal wave treatment will be applied, at a placebo dose and intensity.
Related Therapeutic Areas
Sponsors
Leads: Parc de Salut Mar