Using shock wave therapy to treat lower limb lymphedema
Lower Limb Lymphedema Treatment by Extracorporeal Shock Wave Therapy: Clinical Trial
NA · Parc de Salut Mar · NCT06454734
This study is testing if adding shock wave therapy to regular treatments can help people with lower limb lymphedema feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Parc de Salut Mar (other) |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06454734 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with moderate to severe lower limb lymphedema lasting at least 6 months.
Not a fit: Patients with coagulation disorders, recent deep vein thrombosis, or those unable to walk independently may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of lower limb lymphedema, enhancing patients' quality of life.
How similar studies have performed: While the use of shock wave therapy is a novel approach in this context, similar studies have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Barcelona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphedema, Lower Limb