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Search / Trial NCT06454734

Shock Wave Therapy for Lower Limb Lymphedema

Launched by PARC DE SALUT MAR · Jun 11, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of shock wave therapy on people with lower limb lymphedema, a condition that causes swelling in the legs. The trial will compare two treatment approaches: one group will receive complex decongestive therapy along with actual shock wave therapy, while the other group will receive the same therapy but with a placebo, which is an inactive treatment that looks and feels the same. The goal is to see if shock wave therapy can help reduce swelling and improve the condition.

To participate, individuals must be between 65 and 74 years old and have been experiencing moderate to severe lymphedema affecting their legs for at least six months. Participants should be able to walk independently and must sign a consent form to join. However, those with certain health issues, like blood clotting disorders, recent deep vein thrombosis, or other serious medical conditions, will not be eligible. If you join the trial, you can expect to receive either the active treatment or the placebo, along with regular support from the healthcare team. This trial is currently recruiting participants, and your involvement could help improve treatments for others with this condition in the future.

Gender

ALL

Eligibility criteria

  • 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

About Parc De Salut Mar

Parc de Salut Mar is a leading healthcare institution located in Barcelona, Spain, dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. As a prominent sponsor, it focuses on a wide range of therapeutic areas, emphasizing collaboration between multidisciplinary teams of healthcare professionals and researchers. The institution is committed to adhering to the highest ethical standards and regulatory guidelines, ensuring the safety and well-being of participants while contributing to the development of cutting-edge treatments and therapies. With state-of-the-art facilities and a strong emphasis on patient-centered care, Parc de Salut Mar plays a vital role in the evolving landscape of clinical research.

Locations

Barcelona, , Spain

Patients applied

0 patients applied

Trial Officials

Roser Belmonte, MD, PhD

Principal Investigator

Hospital del Mar

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported