Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorBTL Industries Ltd.
Industry-sponsored
Locations1 site (Ostrava)
StatusRecruiting
StartedOctober 15, 2026
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedOctober 28, 2026
Trial IDNCT07901517 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

  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.