Effects of Vacuum Compression Therapy on Healing of Chronic Lower Limb Ulcers: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in estimated wound volume from baseline at 4 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Vacuum Compression Therapy plus Standard Care
Participants in this arm receive 12 sessions of adjunctive vacuum compression therapy (VCT) in addition to standardized wound care over a 4-week period.
干预措施: Vacuum Compression Therapy (VCT) (Device)
Vacuum Compression Therapy plus Standard Care
Participants in this arm receive 12 sessions of adjunctive vacuum compression therapy (VCT) in addition to standardized wound care over a 4-week period.
干预措施: Standardized Wound Care (Procedure)
Standard Care Alone
Participants in this arm receive standardized wound care alone over a 4-week period.
干预措施: Standardized Wound Care (Procedure)
结局指标
主要结局
Change in estimated wound volume from baseline at 4 weeks
时间窗: 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.
次要结局
- Change in wound length, width, and depth(Baseline (Day 0) and Post-treatment (Week 4))
- Change in Wound-Related Quality of Life (Wound-QoL) total score(Baseline (Day 0) and Post-treatment (Week 4))
- Change in pain intensity(Baseline (Day 0) and Post-treatment (Week 4))
- Change in wound exudate level(Baseline (Day 0) and Post-treatment (Week 4))
- Change in transcutaneous oxygen partial pressure (TcPO2) at the dorsum of the foot(Baseline (Day 0) and Post-treatment (Week 4))
- Change in transcutaneous oxygen partial pressure TcPO2 at the subclavian region(Baseline (Day 0) and Post-treatment (Week 4))
- Change in wound depth(Baseline (Day 0) and Post-treatment (Week 4))
- Change in wound width(Baseline (Day 0) and Post-treatment (Week 4))
- Change in wound length(Baseline (Day 0) and Post-treatment (Week 4))