Diabetic Foot Ulcer, Leg Ulcers, Skin Ulcer, Varicose Ulcers
Conditions
Keywords
Lower Extremity, Intermittent Pneumatic Compression Devices, Ulcer, Wound Healing, Wound Closure Techniques
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.
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.
Interventions
PROCEDUREStandardized 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.
DEVICEVacuum 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.
Sponsors
BTL Industries Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in estimated wound volume from baseline at 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wound-Related Quality of Life (Wound-QoL) total score | Baseline (Day 0) and Post-treatment (Week 4) | 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). |
| Change in pain intensity | Baseline (Day 0) and Post-treatment (Week 4) | 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. |
| Change in wound exudate level | Baseline (Day 0) and Post-treatment (Week 4) | Evaluated using a semi-quantitative 4-point scale: 0 = none, 1 = mild, 2 = moderate, 3 = heavy exudation. Higher scores indicate greater exudate volume. |
| Change in transcutaneous oxygen partial pressure (TcPO2) at the dorsum of the foot | Baseline (Day 0) and Post-treatment (Week 4) | 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). |
| Change in transcutaneous oxygen partial pressure TcPO2 at the subclavian region | Baseline (Day 0) and Post-treatment (Week 4) | 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). |
| Change in wound depth | Baseline (Day 0) and Post-treatment (Week 4) | 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. |
| Change in wound width | Baseline (Day 0) and Post-treatment (Week 4) | 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. |
| Change in wound length | Baseline (Day 0) and Post-treatment (Week 4) | 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. |
Countries
Czechia
Contacts
PRINCIPAL_INVESTIGATORLenka Krupová, Mgr., Ph.D.
Department of Dermatology, University Hospital Ostrava, Ostrava, Czech Republic
Outcome results
None listed