An interventional study of Vacuum Compression Therapy (VCT) and Standard Wound Care in Leg Ulcers and Leg Ulcers Venous, sponsored by BTL Industries Ltd.. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
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.
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.
385 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
This study's planned enrollment of 20 is below the median of 63 across 330 interventional studies indexed under Varicose Ulcer.
Browse Varicose 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.
Compared within Varicose Ulcer, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Leg Ulcer. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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.
Device: Vacuum Compression Therapy (VCT) · Other: Standard Wound Care
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.
Other: Standard Wound Care
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.
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.
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.
Time frame: 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.
Time frame: Baseline and Week 4 (post-treatment)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 4 (post-treatment)
Other open studies at Department of Dermatology, University Hospital Ostrava, Ostrava
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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.
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
Of 67 industry-sponsored interventional studies with no phase under Varicose Ulcer, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 37. This study's planned 2 months is below that.
Counting every sponsor, half of 133 studies reached it within 28 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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