Recruiting NA Lymphedema, Lower Limb

New treatment option for Lymphedema, Lower Limb

Official title Shock Wave Therapy for Lower Limb Lymphedema

ClinicalTrials.gov ID: NCT06454734

What this study is testing

What it's testing
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.
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Barcelona, Spain

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.