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Vacuum Compression Therapy for Chronic Lower Limb Ulcers

NCT07737184 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

  • Leg Ulcers
  • Diabetic Foot Ulcer
  • Varicose Ulcers
  • Skin Ulcer

Interventions

DEVICE

Vacuum Compression Therapy (VCT)

Application of cyclical positive and negative pressure to the affected lower limb using a sealed transparent chamber connected to a vacuum-compression device (BTL Industries Ltd., Prague, Czech Republic). Administered 3 times per week over 4 weeks for a total of 12 sessions (20-30 minutes per session). Operating parameters: positive pressure ranges between 6 and 8 kPa, and negative pressure ranges between -4 and -8 kPa, allowing for at least 10 alternating cycles per session.

PROCEDURE

Standardized Wound Care

Standardized wound management protocol comprising wound cleansing using a hypochlorous irrigation solution, indication-based application of a wound gel, a silver-containing hydrofiber primary dressing, and a standardized secondary dressing. Dressings were changed according to standard clinical routines.

Sponsors & Collaborators

  • BTL Industries Ltd.

    lead INDUSTRY

Principal Investigators

  • Lenka Krupová, Mgr., Ph.D. · Department of Dermatology, University Hospital Ostrava, Ostrava, Czech Republic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07737184 on ClinicalTrials.gov