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Completed
NCT07737184
Vacuum Compression Therapy for Chronic Lower Limb Ulcers
Conditions: Leg Ulcers, Diabetic Foot Ulcer, Varicose Ulcers, Skin Ulcer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: BTL Industries Ltd.
Location: Department of Dermatology, University Hospital Ostrava Ostrava Czechia
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.
Eligibility Criteria
Inclusion Criteria:
* adult patients (≥18 years) with chronic lower limb ulcers of ischemic, venous, diabetic, or post-traumatic 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
Source: ClinicalTrials.gov (NCT07737184). StuddyBuddy aggregates publicly available trial information.