Leg UlcersNCT07737184
Vacuum Compression Therapy for Chronic Lower Limb Ulcers
A study testing Vacuum Compression Therapy (VCT) and Standardized Wound Care in people with Leg Ulcers and Diabetic Foot Ulcer, run by BTL Industries Ltd. at 1 site in Czechia.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcers, Diabetic Foot Ulcer, Varicose Ulcers
- What is being tested?
- Vacuum Compression Therapy (VCT) and Standardized Wound Care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Dermatology, University Hospital Ostrava
Ostrava, Czechia, 708 52
About this study
Official title: Effects of Vacuum Compression Therapy on Healing of Chronic Lower Limb Ulcers: A Randomized Controlled Study
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Leg Ulcers, Diabetic Foot Ulcer, Varicose Ulcers, Skin Ulcer
- Being tested
- Vacuum Compression Therapy (VCT), Standardized Wound Care
- Keywords
- Lower Extremity, Intermittent Pneumatic Compression Devices, Ulcer, Wound Healing, Wound Closure Techniques
- Medical subject headings
- Leg Ulcer, Diabetic Foot, Varicose Ulcer, Skin Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum Compression Therapy (VCT)Device
Also called Intermittent vacuum compression therapy
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.
Standardized Wound CareProcedure or surgery
Also called Conventional wound management
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standardized Wound Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0) and Post-treatment (Week 4)
Secondary outcomes (8)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0) and Post-treatment (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jul 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leg UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lenka Krupová, Mgr., Ph.D., Principal investigator, Department of Dermatology, University Hospital Ostrava, Ostrava, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737184
- Sponsor's protocol ID
- 271/2024
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data will be shared upon request.
Publications
Krupova L, Koliba M, Vantuchova Y, Jetmar V, Olsar M, Mutka J, Nejedla M. Effects of Vacuum Compression Therapy on Healing of Chronic Lower Limb Ulcers: A Randomised Controlled Study. Int Wound J. 2026 Sep;23(9):e71041. doi: 10.1111/iwj.71041.
PubMed 42730491
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vacuum Compression Therapy on Healing of Chronic Lower Limb Ulcers: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07737184
- Acronym / sponsor ID
- 271/2024
- Conditions
- Leg Ulcers, Diabetic Foot Ulcer, Varicose Ulcers, Skin Ulcer
- Keywords
- Lower Extremity, Intermittent Pneumatic Compression Devices, Ulcer, Wound Healing, Wound Closure Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vacuum Compression Therapy plus Standard Care | Experimental | Device: Vacuum Compression Therapy (VCT), Procedure: Standardized Wound CareParticipants in this arm receive 12 sessions of adjunctive vacuum compression therapy (VCT) in addition to standardized wound care over a 4-week period. |
| Standard Care Alone | Active comparator | Procedure: Standardized Wound CareParticipants in this arm receive standardized wound care alone over a 4-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum Compression Therapy (VCT)Also: Intermittent vacuum compression therapyApplication 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. | Device | Vacuum Compression Therapy plus Standard Care |
| Standardized Wound CareAlso: Conventional wound managementStandardized 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. | Procedure or surgery | Standard Care Alone, Vacuum Compression Therapy plus Standard Care |
Primary outcome
Change in estimated wound volume from baseline at 4 weeks
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
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.
8 secondary outcomes
Change in Wound-Related Quality of Life (Wound-QoL) total score
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in pain intensity
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in wound exudate level
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in transcutaneous oxygen partial pressure (TcPO2) at the dorsum of the foot
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in transcutaneous oxygen partial pressure TcPO2 at the subclavian region
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in wound depth
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in wound width
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Change in wound length
Time frame: Baseline (Day 0) and Post-treatment (Week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Derived from this study: PubMed 42730491Krupova L, Koliba M, Vantuchova Y, Jetmar V, Olsar M, Mutka J, Nejedla M. Effects of Vacuum Compression Therapy on Healing of Chronic Lower Limb Ulcers: A Randomised Controlled Study. Int Wound J. 2026 Sep;23(9):e71041. doi: 10.1111/iwj.71041.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lenka Krupová, Mgr., Ph.D. principal investigator
Department of Dermatology, University Hospital Ostrava, Ostrava, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vacuum Compression Therapy (VCT) and Standardized Wound Care in people with Leg Ulcers and Diabetic Foot Ulcer, run by BTL Industries Ltd. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in estimated wound volume from baseline at 4 weeks (time frame: Baseline (Day 0) and Post-treatment (Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07737184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.