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Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Sponsor: BTL Industries Ltd.
Summary
Chronic lower limb ulcers, particularly those of venous etiology, are difficult-to-heal wounds that severely affect patients' quality of life. Adequate tissue oxygenation is essential for wound healing. This study investigates the effects of vacuum compression therapy (VCT) on local tissue oxygenation and wound healing in patients with chronic venous lower limb ulcers. Patients will be randomly divided into two groups: an experimental group receiving VCT alongside standard wound care, and a control group receiving standard wound care alone. The main goal is to compare tissue oxygen levels between the treated (diseased) leg and the untreated (healthy) leg, as well as between the two patient groups before and after therapy. Researchers will also closely monitor how the wounds heal over time using standard clinical measurements and advanced digital photograph analysis (Fiji software). The findings will help determine if VCT specifically increases oxygenation in the treated limb and accelerates wound closure compared to standard care.
Official title: Bilateral Assessment of Microvascular Tissue Oxygenation and Digital Planimetry in Chronic Lower Limb Ulcers Treated With Adjunctive Vacuum Compression Therapy: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-10-15
Completion Date
2026-12-31
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Vacuum Compression Therapy (VCT)
VCT is administered using a specialized extremity chamber that applies cyclically alternating positive (overpressure, approx. 6-8 kPa) and negative (underpressure, approx. -4 to -8 kPa) pressure phases to the affected lower limb. The therapy is designed to enhance local microcirculation and venous return. Patients will undergo VCT sessions 3 times per week for a duration of 4 weeks (12 sessions total), each lasting approximately 20 to 30 minutes, in addition to standard wound care.
Standard Wound Care
To ensure consistency of treatment conditions, all participants will receive standardized wound management. Wounds will be cleansed using a standardized irrigation solution. A silver-containing hydrofiber dressing will be used as the primary dressing. For heavily exuding wounds, the silver hydrofiber dressing will be applied alone; for mildly to moderately exuding wounds, it will be combined with a cleansing gel. The same type of secondary dressing will be used consistently across all patients. This care is provided over a 4-week period.
Locations (1)
Department of Dermatology, University Hospital Ostrava
Ostrava, Czechia