Treatment of Chronic Wounds With Cold Plasma -Plasma Care® vs. Placebo: a Multicenter, Two-arm, Randomized, Single-blind, Prospective, Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Wound area at the end of the study
研究概览
简要总结
Objective: The study aimed to evaluate the wound healing effects of plasma care®, a cold atmospheric plasma device, in patients with chronic wounds.
Method: A prospective, multicenter, two-arm, randomized, single-blind clinical trial was conducted to compare the effectiveness of plasma care® versus placebo, both combined with best practice wound care.
详细描述
Chronic wounds present a growing global health challenge, significantly affecting patients' quality of life and imposing high treatment costs. Despite advances in wound care, such as bioactive dressings and specialized medical personnel, effective treatment remains difficult due to the complexity of the wounds and underlying conditions.
Cold atmospheric plasma (CAP) has recently emerged as a promising treatment. CAP is created by ionizing gas with strong electric fields, producing reactive species that stimulate human cell regeneration while also exhibiting strong antibacterial and antifungal effects-even against antibiotic-resistant strains. This dual action makes CAP especially useful for chronic wounds, which are prone to infections.
CAP also benefits wound healing by lowering wound pH. Chronic wounds often have an alkaline environment conducive to bacterial growth, but CAP shifts the pH toward more acidic levels, supporting cell function and antibacterial activity.
Clinical studies have shown CAP significantly improves wound healing by promoting granulation tissue formation, reducing wound size and infection, and alleviating symptoms like redness and itching. CAP has also proven safe, with no mutagenic effects on healthy cells.
Different technologies exist to generate CAP, including Dielectric Barrier Discharge (DBD), Plasma Jet, and Surface Micro Discharge (SMD). The plasma care® device used in this study is based on SMD technology, allowing mobile, gas-free use to treat areas up to 13 cm², with treatment dose determined by application duration.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 95 years at the time of consent
- •Presence of chronic wounds of any origin and wound phase (Includes locally infected wounds)
- •Wound size up to 20 x 10 cm (If multiple wounds are present, one wound is designated as the study wound)
排除标准
- •Pregnant and breastfeeding women
- •Patients on ongoing systemic antibiotic therapy or who received antibiotics within 1 week prior to study start
- •Patients who participated in another study within one month prior to this study
- •Patients with acute wounds
- •Wounds with visible tendons and bones
- •Wounds with more than 30% dry necrosis
- •Allergy or intolerance to cold plasma
- •Patients with wounds covered by primary or secondary dressings
研究组 & 干预措施
Plasma arm
Treatment of patients with cold atmospheric plasma
干预措施: Cold atmospheric plasma (Device)
Placebo arm
Placebo control
干预措施: Placebo treatment (Device)
结局指标
主要结局
Wound area at the end of the study
时间窗: 42 days
Size of the wound area (absolute) in cm2
Size and time course of the wound area at the end of the study
时间窗: 42 days
Average time course in size (absolute) of the wound area in cm2 per visit
Percentage change in wound area at the end of the study
时间窗: 42 days
Wound area as a percentage (from baseline)
Dynamics of the percentage change in wound area from baseline
时间窗: 42 days
Average time course of the percentage in wound area (compared to the initial value)
次要结局
- Infection Score(42 days)
- pH value(42 days)
- Pain Score(42 days)
- Subjective sensation(42 days)
- Tolerability of treatment(42 days)