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Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers

RecruitingNAAges 18 Years - anyAllBTL Industries Ltd.
NCT07901517 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * adult patients (≥18 years) with chronic lower limb ulcers of venous etiology that had persisted despite appropriate standard therapy and showed no significant signs of healing progression over a one-month period Exclusion Criteria: * age under 18 years, * inability to cooperate with study procedures, * clinically significant infection requiring systemic antibiotic therapy, * active oncological disease, severe uncontrolled pain, and * any contraindications to vacuum compression therapy
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What it tests

  • Vacuum Compression Therapy (VCT)
  • Standard Wound Care
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Where

1 site
Department of Dermatology, University Hospital Ostrava
Ostrava, Czechia
🤝 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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