Leg UlcersNCT07901517
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
A study testing Vacuum Compression Therapy (VCT) and Standard Wound Care in people with Leg Ulcers and Leg Ulcers Venous, run by BTL Industries Ltd. at 1 site in Czechia.
Trial summary
Chronic lower limb ulcers, particularly those of venous etiology, are difficult-to-heal wounds that severely affect patients' quality of life. Adequate tissue oxygenation is essential for wound healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcers, Leg Ulcers Venous
- What is being tested?
- Vacuum Compression Therapy (VCT) and Standard Wound Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Oct 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 venous 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. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Department of Dermatology, University Hospital Ostrava
Ostrava, 708 52
Lenka Krupová, Mgr., Ph.D, +420 737208139, lenka.krupova@fno.cz
About this study
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
Chronic lower limb ulcers, particularly those of venous etiology, are difficult-to-heal wounds that severely affect patients' quality of life. Adequate tissue oxygenation is essential for wound healing. This study investigates the effects of vacuum compression therapy (VCT) on local tissue oxygenation and wound healing in patients with chronic venous lower limb ulcers.
Patients will be randomly divided into two groups: an experimental group receiving VCT alongside standard wound care, and a control group receiving standard wound care alone. The main goal is to compare tissue oxygen levels between the treated (diseased) leg and the untreated (healthy) leg, as well as between the two patient groups before and after therapy. Researchers will also closely monitor how the wounds heal over time using standard clinical measurements and advanced digital photograph analysis (Fiji software). The findings will help determine if VCT specifically increases oxygenation in the treated limb and accelerates wound closure compared to standard care.
Read the detailed description
Adequate microvascular perfusion and tissue oxygenation are critical prerequisites for the healing of chronic lower limb ulcers. Vacuum compression therapy (VCT) is an adjunctive biophysical modality designed to enhance local hemodynamics through the cyclic alternation of positive and negative pressure applied to the affected limb.This prospective, parallel-group, randomized controlled trial aims to systematically evaluate the specific localized effects of VCT on microvascular tissue oxygenation (measured as transcutaneous oxygen partial pressure, TcPO2) and wound healing dynamics in patients with venous leg ulcers. Patients will be randomly assigned to either an experimental group receiving VCT plus standard care or a control group receiving standard care alone. To rigorously differentiate localized treatment effects from systemic variations and non-specific healing responses, the study employs both inter-group and intra-patient control mechanisms. TcPO2 will be measured simultaneously at multiple sites in both groups: the dorsum of the foot on the ulcerated limb, the dorsum of the foot on the contralateral unaffected limb (intra-patient control), the calf region of the ulcerated limb, and the subclavian region (systemic reference).In addition to physiological monitoring, wound reduction will be tracked via standard clinical dimensions (length × width × depth) and quantitative digital planimetry. Standardized clinical photographs will be analyzed using Fiji (ImageJ) software to calculate accurate wound area reduction. By combining multi-site physiological oxygenation mapping with advanced digital wound morphometry across two study arms, this trial seeks to provide definitive evidence regarding the microcirculatory and healing mechanisms of VCT.
- Conditions
- Leg Ulcers, Leg Ulcers Venous
- Being tested
- Vacuum Compression Therapy (VCT), Standard Wound Care
- Keywords
- Lower Extremity, Ulcer, Wound Healing, Wound Closure Techniques
- Medical subject headings
- Leg Ulcer, Varicose 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
VCT is administered using a specialized extremity chamber that applies cyclically alternating positive (overpressure, approx. 6-8 kPa) and negative (underpressure, approx. -4 to -8 kPa) pressure phases to the affected lower limb. The therapy is designed to enhance local microcirculation and venous return. Patients will undergo VCT sessions 3 times per week for a duration of 4 weeks (12 sessions total), each lasting approximately 20 to 30 minutes, in addition to standard wound care.
Standard Wound CareOther
To ensure consistency of treatment conditions, all participants will receive standardized wound management. Wounds will be cleansed using a standardized irrigation solution. A silver-containing hydrofiber dressing will be used as the primary dressing. For heavily exuding wounds, the silver hydrofiber dressing will be applied alone; for mildly to moderately exuding wounds, it will be combined with a cleansing gel. The same type of secondary dressing will be used consistently across all patients. This care is provided over a 4-week period.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: VCT + Standard Care | Experimental | Patients will receive standardized wound care combined with a 4-week regimen of Vacuum Compression Therapy (VCT). VCT is administered cyclically three times a week. TcPO2 will be assessed bilaterally (diseased and healthy limb) before and after the 4-week period. Receives: Device: Vacuum Compression Therapy (VCT); Other: Standard Wound Care |
| Control Group: Standard Care | Active comparator | Patients will receive standardized clinical wound care only, matched in duration and frequency to the experimental group. No VCT will be applied. TcPO2 will be assessed bilaterally (diseased and healthy limb) before and after the 4-week period. Receives: Other: Standard Wound Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bilateral Foot Transcutaneous Oxygen Partial Pressure (TcPO2)
Measured in mmHg on the dorsum of the foot in both the ulcerated (treated) limb and the contralateral unaffected (untreated) limb in both study groups using transcutaneous oxygen monitoring. Higher values indicate improved local microvascular tissue oxygenation.
Measured: Baseline and Week 4 (post-treatment)
Change in Wound Surface Area Assessed by Digital Planimetry
Measured in square centimeters (cm2) using standardized clinical photographs analyzed with Fiji (ImageJ) software. Tracing of wound margins provides precise measurement of two-dimensional wound area reduction. A reduction in the measured surface area from baseline to Week 4 indicates clinical improvement and wound healing.
Measured: Baseline and Week 4 (post-treatment)
Secondary outcomes (4)
Change in Regional (Calf) and Systemic (Subclavian) Transcutaneous Oxygen Partial Pressure (TcPO2)
Measured in mmHg at the calf region of the ulcerated (diseased) limb only and at the subclavian reference site across both study groups. These measurements evaluate regional periwound perfusion changes on the affected limb versus systemic baseline oxygenation.
Measured: Baseline and Week 4 (post-treatment)
Change in Wound Length
The maximum linear dimension of the wound measured in centimeters (cm) using a standard single-use clinical ruler.
Measured: Baseline and Week 4 (post-treatment)
Change in Wound Width
The maximum linear dimension perpendicular to the wound length, measured in centimeters (cm) using a standard single-use clinical ruler.
Measured: Baseline and Week 4 (post-treatment)
Change in Wound Depth
The maximum vertical distance from the skin surface to the deepest point of the wound bed, measured in centimeters (cm) using a sterile probe/ruler.
Measured: Baseline and Week 4 (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- A randomized, two-arm parallel design where patients are allocated to either an experimental group (VCT + standard care) or a control group (standard care alone). Furthermore, the study utilizes an intra-patient control mechanism by assessing TcPO2 bilaterally on both the ulcerated and contralateral unaffected limbs in all participants.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
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
- NCT07901517
- Sponsor's protocol ID
- VCT-FNO/2026
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07901517
- Acronym / sponsor ID
- VCT-FNO/2026
- Conditions
- Leg Ulcers, Leg Ulcers Venous
- Keywords
- Lower Extremity, Ulcer, Wound Healing, Wound Closure Techniques
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Oct 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.
Chronic lower limb ulcers, particularly those of venous etiology, are difficult-to-heal wounds that severely affect patients' quality of life. Adequate tissue oxygenation is essential for wound healing. This study investigates the effects of vacuum compression therapy (VCT) on local tissue oxygenation and wound healing in patients with chronic venous lower limb ulcers.
Patients will be randomly divided into two groups: an experimental group receiving VCT alongside standard wound care, and a control group receiving standard wound care alone. The main goal is to compare tissue oxygen levels between the treated (diseased) leg and the untreated (healthy) leg, as well as between the two patient groups before and after therapy. Researchers will also closely monitor how the wounds heal over time using standard clinical measurements and advanced digital photograph analysis (Fiji software). The findings will help determine if VCT specifically increases oxygenation in the treated limb and accelerates wound closure compared to standard care.
Detailed description
Adequate microvascular perfusion and tissue oxygenation are critical prerequisites for the healing of chronic lower limb ulcers. Vacuum compression therapy (VCT) is an adjunctive biophysical modality designed to enhance local hemodynamics through the cyclic alternation of positive and negative pressure applied to the affected limb.This prospective, parallel-group, randomized controlled trial aims to systematically evaluate the specific localized effects of VCT on microvascular tissue oxygenation (measured as transcutaneous oxygen partial pressure, TcPO2) and wound healing dynamics in patients with venous leg ulcers. Patients will be randomly assigned to either an experimental group receiving VCT plus standard care or a control group receiving standard care alone. To rigorously differentiate localized treatment effects from systemic variations and non-specific healing responses, the study employs both inter-group and intra-patient control mechanisms. TcPO2 will be measured simultaneously at multiple sites in both groups: the dorsum of the foot on the ulcerated limb, the dorsum of the foot on the contralateral unaffected limb (intra-patient control), the calf region of the ulcerated limb, and the subclavian region (systemic reference).In addition to physiological monitoring, wound reduction will be tracked via standard clinical dimensions (length × width × depth) and quantitative digital planimetry. Standardized clinical photographs will be analyzed using Fiji (ImageJ) software to calculate accurate wound area reduction. By combining multi-site physiological oxygenation mapping with advanced digital wound morphometry across two study arms, this trial seeks to provide definitive evidence regarding the microcirculatory and healing mechanisms of VCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, two-arm parallel design where patients are allocated to either an experimental group (VCT + standard care) or a control group (standard care alone). Furthermore, the study utilizes an intra-patient control mechanism by assessing TcPO2 bilaterally on both the ulcerated and contralateral unaffected limbs in all participants.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: VCT + Standard Care | Experimental | Device: Vacuum Compression Therapy (VCT), Other: Standard Wound CarePatients will receive standardized wound care combined with a 4-week regimen of Vacuum Compression Therapy (VCT). VCT is administered cyclically three times a week. TcPO2 will be assessed bilaterally (diseased and healthy limb) before and after the 4-week period. |
| Control Group: Standard Care | Active comparator | Other: Standard Wound CarePatients will receive standardized clinical wound care only, matched in duration and frequency to the experimental group. No VCT will be applied. TcPO2 will be assessed bilaterally (diseased and healthy limb) before and after the 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 venous 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)VCT is administered using a specialized extremity chamber that applies cyclically alternating positive (overpressure, approx. 6-8 kPa) and negative (underpressure, approx. -4 to -8 kPa) pressure phases to the affected lower limb. The therapy is designed to enhance local microcirculation and venous return. Patients will undergo VCT sessions 3 times per week for a duration of 4 weeks (12 sessions total), each lasting approximately 20 to 30 minutes, in addition to standard wound care. | Device | Experimental Group: VCT + Standard Care |
| Standard Wound CareTo ensure consistency of treatment conditions, all participants will receive standardized wound management. Wounds will be cleansed using a standardized irrigation solution. A silver-containing hydrofiber dressing will be used as the primary dressing. For heavily exuding wounds, the silver hydrofiber dressing will be applied alone; for mildly to moderately exuding wounds, it will be combined with a cleansing gel. The same type of secondary dressing will be used consistently across all patients. This care is provided over a 4-week period. | Other | Control Group: Standard Care, Experimental Group: VCT + Standard Care |
Primary outcome
Change in Bilateral Foot Transcutaneous Oxygen Partial Pressure (TcPO2)
Time frame: Baseline and Week 4 (post-treatment)
Measured in mmHg on the dorsum of the foot in both the ulcerated (treated) limb and the contralateral unaffected (untreated) limb in both study groups using transcutaneous oxygen monitoring. Higher values indicate improved local microvascular tissue oxygenation.
Change in Wound Surface Area Assessed by Digital Planimetry
Time frame: Baseline and Week 4 (post-treatment)
Measured in square centimeters (cm2) using standardized clinical photographs analyzed with Fiji (ImageJ) software. Tracing of wound margins provides precise measurement of two-dimensional wound area reduction. A reduction in the measured surface area from baseline to Week 4 indicates clinical improvement and wound healing.
4 secondary outcomes
Change in Regional (Calf) and Systemic (Subclavian) Transcutaneous Oxygen Partial Pressure (TcPO2)
Time frame: Baseline and Week 4 (post-treatment)
Change in Wound Length
Time frame: Baseline and Week 4 (post-treatment)
Change in Wound Width
Time frame: Baseline and Week 4 (post-treatment)
Change in Wound Depth
Time frame: Baseline and Week 4 (post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- 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.
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 Standard Wound Care in people with Leg Ulcers and Leg Ulcers Venous, 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: looking for participants now, as of the sponsor's last update on 28 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lenka Krupová, Mgr., Ph.D. (+420 737208139, lenka.krupova@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bilateral Foot Transcutaneous Oxygen Partial Pressure (TcPO2) (time frame: Baseline and Week 4 (post-treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.