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Vacuum Compression Therapy for Chronic Lower Limb Ulcers
Sponsor: BTL Industries Ltd.
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.
Official title: Effects of Vacuum Compression Therapy on Healing of Chronic Lower Limb Ulcers: A Randomized Controlled Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-07-01
Completion Date
2025-12-31
Last Updated
2026-07-30
Healthy Volunteers
No
Interventions
Vacuum Compression Therapy (VCT)
Application of cyclical positive and negative pressure to the affected lower limb using a sealed transparent chamber connected to a vacuum-compression device (BTL Industries Ltd., Prague, Czech Republic). Administered 3 times per week over 4 weeks for a total of 12 sessions (20-30 minutes per session). Operating parameters: positive pressure ranges between 6 and 8 kPa, and negative pressure ranges between -4 and -8 kPa, allowing for at least 10 alternating cycles per session.
Standardized Wound Care
Standardized wound management protocol comprising wound cleansing using a hypochlorous irrigation solution, indication-based application of a wound gel, a silver-containing hydrofiber primary dressing, and a standardized secondary dressing. Dressings were changed according to standard clinical routines.
Locations (1)
Department of Dermatology, University Hospital Ostrava
Ostrava, Czechia, Czechia