Clinical Trial

Vacuum Compression Therapy for Chronic Lower Limb Ulcers

Completed
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Summary
The goal of this clinical trial is to learn if vacuum compression therapy added to standard care improves wound healing in adults with chronic lower limb ulcers. The main questions it aims to answer are: * Does vacuum compression therapy lead to a greater reduction in wound volume compared to standard wound care alone? * Does vacuum compression therapy improve local tissue oxygenation, wound-related pain, and patient quality of life? Researchers will compare patients receiving vacuum compression therapy plus standard wound care to those receiving standard wound care alone to see if the combined treatment accelerates healing and improves quality of life. Participants will: * Receive standardized wound care (wound cleansing and specific dressings) over a 4-week period. * If assigned to the therapy group, undergo 12 sessions of vacuum compression therapy (20 to 30 minutes per session, 3 times per week for 4 weeks) on the affected leg. * Complete assessments of wound size, pain intensity, quality of life, and local tissue oxygenation at the start and at the end of the 4-week study.
Trial Details
NCT Number NCT07737184
Lead Sponsor BTL Industries Ltd.
Conditions Leg Ulcers, Diabetic Foot Ulcer, Varicose Ulcers, Skin Ulcer
Enrollment 50 participants
Start Date 2024-07-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-03