Treatment of the Hypertensive Leg Ulcers by PRF Application
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Pain auto evaluation (spontaneous and caused by local care)
研究概览
简要总结
Hypertensive leg ulcers are very painful and difficult to treat ulcers. Their treatment is not well established.
We want to study the efficacy of PRF applications on the pains related to those ulcers.
PRF (Platelet-Rich Fibrin) is an autologous fibrin clot, obtained extemporaneously from patient's blood, without any additive nor complex manipulation. It contains blood platelets and white blood cells, trapped in fibrin during clot formation.
PRF (Platelet-Rich Fibrin) is form immediately after blood punction in a dry tube, that does not contain any anticoagulant. Coagulation naturally occurs within few minutes, and tubes are placed in a centrifuge: red blood cells are separated from the fibrin clot thanks to difference of density, and blood platelets and white blood cells are trapped in the fibrin clot.
The fibrin clot is then rapidly applicated on the ulcer surface for four days. Our hypothesis is that platelet growth factors and cytokines, liberated during platelet activation, could help to treat hypertensive leg ulcers, that are caused by a vascular spasm.
详细描述
2 to 8 PRF (depending on the ulcer surface), applied on painful hypertensive leg ulcer, and covered by a dressing for 4 days.
Afterwards, dressings are made in a classical way. If needed (persistence of important pain), the PRF application can be repeated after 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •hypertensive leg ulcer
- •important pain (>= 5/10)
排除标准
- •significant venous deficiency
- •significant arterial deficiency
- •other leg ulcers
- •any active diseases such as infection, neoplasia, auto-immune disease
研究组 & 干预措施
PRF application
干预措施: PRF (Platelet-Rich Fibrin) (Procedure)
结局指标
主要结局
Pain auto evaluation (spontaneous and caused by local care)
时间窗: Pain was assessed by self-assessment Single Digital Scale - Pain felt in the past 24 hours;
- Pain experienced during the last ulcer care. Ulcers are described using the: * Size * Presence or absence of necrosis on the bottom and banks * Presence or absence of purplish banks
次要结局
未报告次要终点