CompletedNot Applicable

Vacuum Compression Therapy for Chronic Lower Limb Ulcers

Czechia50 participantsStarted 2024-07-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in estimated wound volume from baseline at 4 weeks

Timeframe: Baseline (Day 0) and Post-treatment (Week 4)

Trial details

NCT IDNCT07737184

SponsorBTL Industries Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Leg Ulcers trials