Vacuum Compression Therapy for Venous Leg Ulcers
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
Run by BTL Industries Ltd. · NCT07901517 · Data updated 2026-11-12
This study tests whether adding vacuum compression therapy to standard wound care helps heal chronic venous leg ulcers by increasing local tissue oxygenation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | BTL Industries Ltd. Industry-sponsored |
| Locations | 1 site (Ostrava) |
| Status | Recruiting |
| Started | October 15, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07901517 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with chronic venous leg ulcers that have not progressed with standard therapy for at least one month.
✕Probably not a fit
Patients without adequate response to VCT or with contraindications may not experience the intended oxygenation or healing benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial compares vacuum compression therapy plus standard wound care versus standard wound care alone in adults with chronic venous leg ulcers. Local tissue oxygenation is measured on both the affected and contralateral limbs, and wound healing is tracked over time using clinical measurements and digital planimetry with Fiji software. The aim is to determine if VCT can improve microvascular oxygen delivery and accelerate wound closure compared with standard care. Inter-group and intra-patient controls help separate treatment effects from systemic healing variation. TcPO2, wound dimensions, and photographic analyses are used to quantify outcomes.
Why it matters
Potential benefit: If successful, patients could experience faster wound healing and better local tissue oxygenation with VCT as an adjunct to standard care.
How similar studies have gone: Prior studies of biophysical therapies for venous ulcers have shown variable but often encouraging effects on wound healing and perfusion in similar populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Department of Dermatology, University Hospital Ostrava
Ostrava, Czechia Recruiting
Study contacts
- Principal investigator: Lenka Krupová, Mgr., Ph.D. — Department of Dermatology, University Hospital Ostrava, Ostrava, Czech Republic
- Study coordinator: Lenka Krupová, Mgr., Ph.D.
- Email: lenka.krupova@fno.cz
- Phone: +420 737208139
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This trial will try human placental membrane products together with standard wound care to help adults whose diabetic foot ulcers or venous leg ulcers have not healed.
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This study is testing a new light compression system to see if it helps adults with mixed leg ulcers heal better than a regular bandage.
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This study tests if music therapy can help reduce pain for adults getting treatment for leg ulcers.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.