Application of Platelet-rich Plasma for Healing og Grade III Ulcer.
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in ulcer diameter at 30, 60, and 90 days
研究概览
简要总结
Treatment with platelet-rich plasma (PRP) consists of extracting a small amount of blood from the patient himself, which is later processed by centrifugation to obtain a fraction rich in platelets. It will be done on weekly or fortnightly blood extraction procedure, depending on the process. Between 1-3 sterile citrate collection tubes will be used, which may vary depending on the size of the ulcer. Each tube can contain approximately 8-10ml of blood and the procedure is carried out under aseptic conditions and with material from a single use Once the sample has been centrifuged, the blood plasma will be extracted and the concentrate obtained will be applied directly on the wound or ulcer with the objective of stimulating and accelerating healing by means of growth factors.
This procedure is used as complementary therapy in chronic ulcers or with difficulty in healing, such as they can be venous, arterial, pressure or diabetic foot ulcers.
详细描述
- Introduction
Platelet-rich plasma (PRP) is an autologous blood derivative obtained by centrifuging the patient's own blood. It contains a high concentration of growth factors that promote tissue regeneration and cell proliferation. Its use in the treatment of chronic ulcers has shown good results, especially in wounds that do not respond to conventional treatments. 2. Required Materials
Sterile 5 ml and 10 ml syringes
Needles or butterfly needle and 20G vacutainer for extraction, and 30G (4 mm or 13 mm) for infiltration
Tube with anticoagulant (3.8% sodium citrate), closed system technique
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
- •Patients with Grade III ulcers.
- •Patients with ulcers older than two weeks.
- •Patients with an optimal platelet count according to prior laboratory tests.
排除标准
- •Patients with a palliative profile.
- •Patients with a limited life expectancy.
- •Patients with a platelet count below 10 × 10⁹/L
结局指标
主要结局
Change in ulcer diameter at 30, 60, and 90 days
时间窗: At the beginning of patient inclusion and at 30, 60, and 90 days from the start of therapy
次要结局
- Scoring on the PUSH Scale(At the beginning of the study, and at 30, 60, and 90 days from the start of the therapy)
- Amount of Exudate(At the time of patient inclusion, and at 30, 60, and 92 days from the start of treatment)