Vacuum Compression Therapy for Chronic Lower Limb Ulcers

NCT07737184 | Completed

• 1 other identifier: 271/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lower Extremity; Intermittent Pneumatic Compression Devices; Ulcer; Wound Healing; Wound Closure Techniques

Outcome Measures

Primary Outcomes (1)

• Change in estimated wound volume from baseline at 4 weeks

  Wound length, width, and depth are measured using a single-use paper ruler alongside digital photography with a standardized measurement scale. Estimated wound volume is calculated using the three-dimensional approximation formula: Volume = length × width × depth The primary outcome is evaluated as the change in estimated wound volume cm3 from baseline to post-treatment evaluation.

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

Secondary Outcomes (6)

• Change in wound length, width, and depth

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

• Change in Wound-Related Quality of Life (Wound-QoL) total score

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

• Change in pain intensity

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

• Change in wound exudate level

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

• Change in transcutaneous oxygen partial pressure (TcPO2) at the dorsum of the foot

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

Study Arms (2)

Vacuum Compression Therapy plus Standard Care

EXPERIMENTAL

Participants in this arm receive 12 sessions of adjunctive vacuum compression therapy (VCT) in addition to standardized wound care over a 4-week period.

Device: Vacuum Compression Therapy (VCT); Procedure: Standardized Wound Care

Standard Care Alone

ACTIVE COMPARATOR

Participants in this arm receive standardized wound care alone over a 4-week period.

Procedure: Standardized Wound Care

Interventions

Vacuum Compression Therapy (VCT) DEVICE

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.

Also known as: Intermittent vacuum compression therapy

Vacuum Compression Therapy plus Standard Care

Standardized Wound Care PROCEDURE

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.

Also known as: Conventional wound management

Standard Care Alone; Vacuum Compression Therapy plus Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

Department of Dermatology, University Hospital Ostrava

Ostrava, Czechia, 708 52, Czechia

Location

MeSH Terms

Conditions

Leg Ulcer; Diabetic Foot; Varicose Ulcer; Skin Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lenka Krupová, Mgr., Ph.D.

  Department of Dermatology, University Hospital Ostrava, Ostrava, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available for 5 years following publication of the study.
• Access Criteria: Data will be shared upon reasonable request to the corresponding author (lenka.krupova@fno.cz) for research purposes.

Locations

CZ (1)