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Clinical Trials in Turkey / NCT07626645
Recruiting Not applicable

Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema

NCT07626645 · tracked via the Priya Life Science Turkey tracker
Sponsor
Gazi University
Phase
Not applicable
Started
2026-09-01
Last updated
2026-09-15

Condition(s) studied

Lymphedema, Lower LimbExtracorporeal Shock Wave TherapyEdema LegSham-controlledPlacebo Control Design

Investigational drug(s) / intervention(s)

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

Extracorporeal Shock Wave Therapy (ESWT): Radial shock wave therapy will be applied using the EMS Swiss DolorClast® device. Each session will consist of 3,000 impulses delivered at 20 Hz and 2 bar using a 40 mm applicator, targeting fibrotic tissue regions and periinguinal and peripopliteal lymph node areas. ESWT will be administered twice weekly for five sessions

Sham Extracorporeal Shock Wave Therapy (Sham ESWT): Sham ESWT will be applied with identical positioning and session duration as the active ESWT group. Only non-energized impulses will be delivered, ensuring participant blinding. Sham ESWT will be administered twice weekly for five sessions.

Study summary

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 by ultrasonography, pain, functional status, and quality of life will be evaluated at baseline, after treatment, and at one-month follow-up.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in Lower Extremity Limb Volume — Baseline, immediately after treatment (week 3), and 1-month follow-up
    Change in lower extremity limb volume calculated using the truncated cone formula. Volume will be estimated from circumferential measurements taken at 4 cm intervals from approximately 2 cm proximal to the medial malleolus to the inguinal region, with the patient in the supine position.

Trial sites (1)

FacilityCityRegionStatus
Gazi University Hospital, Department of Physical Medicine and Rehabilitation, Ankara, 06560 Ankara Yenimahalle Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07626645 on ClinicalTrials.gov ↗ ← All trials in Turkey