Efficacy of Single-use Negative Pressure Therapy With PICO System in Chronic Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Number of participants with adverse effects
研究概览
简要总结
A clinical trial will be carried out comparing the efficacy of PICO system based on negative pressure therapy (NPT) in adults with chronic ulcers compared to conventional treatments.
详细描述
Due to the current scientific and clinical evidence shows that NPT offers guarantees as complementary care, improving healing and reducing amputations in patients with chronic ulcers, treatment with PICO single-use NPT, should be considered as the first option.
This clinical trial include adults from the Hospital General Universitario of Toledo with 2 arms (intervention and control) and the intervention will last 12 weeks.
The intervention proposed in the study will consist of evaluating the decrease in size, the healing rate, the adverse effects and the quality of life related to the health of the patients compared with traditional treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •Both sexes over 18 years.
- •Patients with chronic ulcers: venous leg ulcer, diabetic foot ulcer or pressure ulcers.
- •Patients capable of complying with the protocol instructions and signing the informed consent (IC) or with limited capacity to act, in which case their relatives would be informed, who would be the ones who would grant the signed informed consent.
- •Acceptable state of health.
排除标准
- •Malignant ulcers.
- •Ulcers with abundant exudate.
- •Non-modifiable anatomical location to create hermetic seal of the dressing.
- •Suspected or known allergy to components of TPN systems.
- •Pregnancy.
- •Serious cardiovascular diseases.
- •Diagnosis of vasculitis or claudication.
- •Current administration of systemic chemotherapy or corticosteroids.
- •Having received prior treatment with TPN or hyperbaric oxygen in the 7 days prior to screening.
- •Leukopenia, thrombocytopenia, anemia, increased bilirubin or three times the level of liver enzymes.
- •Deep venous thrombosis.
- •Refusal or inability to tolerate compression therapy, exposure of muscles, tendons or bone.
- •Diagnosis of active Charcot foot syndrome.
- •Malnutrition or eating disorders.
结局指标
主要结局
Number of participants with adverse effects
时间窗: 12 weeks
The nurse will observe how many patients may have adverse effects.
Cure rate
时间窗: 12 weeks
The cure rate will be measured by a nurse during the days of the treatment
Change in the size of wounds
时间窗: 12 weeks
The size of the wound will be measured by a nurse using a ruler every day that the patient goes to the cure to compare de first measure from the last one.
Healing time
时间窗: 12 weeks
The healing time will be measured by a nurse during the days of the treatment
Health-related effects on quality of life.
时间窗: 12 weeks
Patients will answer the European Quality of Life-5 Dimension. This consists of a questionnaire to measure health-related quality of life, before and after the treatment. This scale have two parts: in the first one, 0 is the best score; and 15 is the worst. In the second part (that is a pain rating scale): 0 is the worst state of health imaginable and 10 the best state of health imaginable.
次要结局
未报告次要终点