Extracorporeal Shock Wave Therapy to Help Lower-Limb Lymphedema (with standard CDT)

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 is a single-center, randomized, double-blind, placebo-controlled study comparing active ESWT versus sham ESWT added to ongoing standard CDT maintenance in adults with lower-extremity lymphedema. Participants maintain compression, skin care, and exercise while receiving ESWT twice weekly for five sessions, delivered to fibrotic tissue and nearby lymph node areas. Outcomes include limb volume, skin and subcutaneous tissue thickness by ultrasonography, pain, functional status, and quality of life, assessed at baseline and after treatment. The trial uses stratified randomization by lymphedema stage and keeps all participants on standard CDT throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18 to 80 years
* Clinical diagnosis of lower extremity lymphedema established at least 6 months prior to enrollment
* Completion of at least one cycle of CDT Phase 1 (intensive decongestive phase) within the preceding six months
* Currently in CDT Phase 2 (maintenance phase) with active use of compression garments
* Ability and willingness to provide written informed consent

Exclusion Criteria:

* Active chemotherapy or radiotherapy
* Active infection
* Lower extremity vascular diseases including deep vein thrombosis or arterial insufficiency
* Presence of a cardiac pacemaker
* Pregnancy
* Bleeding disorders

Where it's running

• Gazi University Hospital, Department of Physical Medicine and Rehabilitation, Ankara, 06560
  Ankara, Yenimahalle, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Ayca Utkan Karasu, M.D
• Email: ayca_utkan@yahoo.com
• Phone: +905365759757

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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.