An interventional study of Vacuum Compression Therapy (VCT) and Standardized Wound Care in Leg Ulcers, Diabetic Foot Ulcer and Varicose Ulcers, sponsored by BTL Industries Ltd.. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
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:
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:
Chronic lower limb ulcers of varied etiologies (including venous, arterial/ischemic, diabetic, and post-traumatic) frequently present a therapeutic challenge due to persistent microcirculatory impairment and localized tissue hypoxia. Impaired tissue perfusion hinders key reparative processes, such as cellular proliferation, angiogenesis, and collagen synthesis, contributing to wound chronicity.
Vacuum compression therapy (VCT) is an adjunctive therapeutic modality designed to improve peripheral blood circulation through the application of cyclical alternation between positive (overpressure) and negative (underpressure) pressure phases applied directly to the affected limb placed within a sealed transparent chamber. Functionally, the positive-pressure phase is presumed to facilitate venous return, while the negative-pressure phase stimulates arterial inflow, thereby enhancing dynamic local perfusion and oxygen delivery to the periwound tissue.
In this prospective, single-center, parallel-group trial, participants assigned to the experimental arm received 12 sessions of VCT in addition to standardized wound care over a 4-week intervention period (administered 3 times per week: Monday, Wednesday, Friday; session duration 20-30 minutes). VCT parameters were delivered using a specialized vacuum-compression device (BTL Industries Ltd., Prague, Czech Republic), with positive pressure settings ranging from 6 to 8 kPa and negative pressure settings ranging from -4 to -8 kPa, allowing for at least 10 alternating pressure cycles per session. Continuous visual monitoring through the transparent chamber was conducted to evaluate cutaneous microvascular reactivity and monitor treatment tolerance.
Both the experimental and control groups received identical, standardized wound care protocols to isolate the specific effect of VCT. Standardized care comprised wound cleansing with a hypochlorous irrigation solution, indication-based application of a wound gel, a silver-containing hydrofiber primary dressing, and a standardized secondary dressing.
This exploratory study evaluates the preliminary multidimensional clinical effects of VCT, combining three-dimensional wound morphological measurements, transcutaneous oxygen partial pressure (TcPO₂) assessment, pain evaluation, and health-related quality of life, to inform future larger-scale therapeutic trials.
173 studies on the registry are indexed under Leg Ulcer; 33 are open to participants now.
This study's enrollment of 50 is close to the median of 52 across 135 interventional studies indexed under Leg Ulcer.
Browse Leg Ulcer studies →BTL Industries Ltd. is the lead sponsor of 77 studies on the registry; 5 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants in this arm receive standardized wound care alone over a 4-week period.
Procedure: Standardized Wound Care
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
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
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.
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in Wound-Related Quality of Life (Wound-QoL) total score
Evaluated using the validated 17-item Wound-QoL questionnaire. Each item is scored on a 5-point Likert scale (0 to 4). The total score represents the mean of all items and ranges from 0 to 4, where higher scores indicate worse quality of life (greater impairment).
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in pain intensity
Assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores indicate greater pain intensity.
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in wound exudate level
Evaluated using a semi-quantitative 4-point scale: 0 = none, 1 = mild, 2 = moderate, 3 = heavy exudation. Higher scores indicate greater exudate volume.
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in transcutaneous oxygen partial pressure (TcPO2) at the dorsum of the foot
Measured in mmHg at the dorsum of the affected foot using transcutaneous oxymetry to evaluate local microcirculatory perfusion. Higher values indicate improved local tissue oxygenation. (Measured in the experimental group).
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in transcutaneous oxygen partial pressure TcPO2 at the subclavian region
Measured in mmHg at the subclavian region as a systemic control reference site to distinguish localized microcirculatory changes from systemic oxygenation alterations. Higher values indicate higher systemic oxygen partial pressure. (Measured in the experimental group).
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in wound depth
Linear dimension of the wound depth measured in centimeters (cm) using a single-use paper ruler and verified via digital photography with a standardized measurement scale.
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in wound width
Linear dimension of the wound width measured in centimeters (cm) using a single-use paper ruler and verified via digital photography with a standardized measurement scale.
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in wound length
Linear dimension of the wound length measured in centimeters (cm) using a single-use paper ruler and verified via digital photography with a standardized measurement scale.
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Plan to share: Yes — Anonymized individual participant data will be shared upon request.
Supporting information: 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.
No publications or documents are linked to this record.
Ran from Jul 2024 to primary completion in Dec 2025, 17 months.
Of 38 interventional studies with no phase under Leg Ulcer, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's 17 months is below that.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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