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Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema

RecruitingNAAges 18 Years - 80 YearsAllGazi University
NCT07626645 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Lower extremity lymphedema is a chronic and progressive condition associated with significant functional impairment and reduced quality of life. The current gold-standard treatment is Complex Decongestive Therapy (CDT); however, a substantial proportion of patients continue to experience persistent symptoms during the maintenance phase. This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) as an adjunct to standard CDT maintenance therapy in patients with lower extremity lymphedema. Participants will be randomly allocated to either an active ESWT group or a sham ESWT group, with both groups continuing standard CDT maintenance throughout the study. ESWT will be administered twice weekly for five sessions. Changes in limb volume, skin thickness and subcutaneous tissue thickness assessed b

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📋 Eligibility rules (as published)
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
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What it tests

  • Extracorporeal Shock Wave Therapy (ESWT)
  • Sham Extracorporeal Shock Wave Therapy (Sham ESWT)
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Where

1 site
Gazi University Hospital, Department of Physical Medicine and Rehabilitation, Ankara, 06560
Ankara, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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