Using shock wave therapy to treat lower limb lymphedema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of shock wave therapy combined with complex decongestive therapy for patients suffering from lower limb lymphedema. It involves a double-blind, randomized design with two groups: one receiving the active shock wave therapy and the other receiving a placebo. Both groups will undergo standard treatments including manual lymphatic drainage and compression, with a total of 10 sessions over 5 weeks. The study aims to assess the impact of shock wave therapy on lymphedema symptoms and overall patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital del Mar
  Barcelona, Spain Recruiting

Study contacts

• Principal investigator: Roser Belmonte, MD, PhD — Hospital del Mar
• Study coordinator: Roser Belmonte, MD, PhD
• Email: rbelmonte@psmar.cat
• Phone: +34 933674214

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.