Vacuum Compression Therapy for Chronic Lower Limb Ulcers
Key facts
- Who runs it
- BTL Industries Ltd.
- Where
- Czechia1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 50 people enrolled
- Started
- 1 Jul 2024
- Ended
- 31 Dec 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Vacuum Compression Therapy (VCT)
- Standardized Wound Care
- Record updated
- 3 August 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- any contraindications to vacuum compression therapy
- clinically significant infection requiring systemic antibiotic therapy,
- active oncological disease, severe uncontrolled pain, and
- age under 18 years,
- inability to cooperate with study procedures,
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Vacuum Compression Therapy plus Standard CareTreatment being tested
Participants in this arm receive 12 sessions of adjunctive vacuum compression therapy (VCT) in addition to standardized wound care over a 4-week period.
Treatment: Vacuum Compression Therapy (VCT) and Standardized Wound Care
- Standard Care AloneExisting treatment, for comparison
Participants in this arm receive standardized wound care alone over a 4-week period.
Treatment: Standardized Wound Care
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Vacuum Compression Therapy on Healing of Chronic Lower Limb Ulcers: A Randomized Controlled Study
- Record updated
- 3 August 2026