Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum In The Treatment Of Recalcitrant Venous Stasis Ulcers
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number and type adverse events
研究概览
简要总结
The aim of this study is to
- To evaluate the safety and tolerability of Platelet Rich plasma(PRP)/Thrombin mixture in treating chronic venous ulcers
- To evaluate efficacy of PRP/Thrombin mixture in treating chronic venous ulcers
详细描述
Study rationale
In normal wound healing, platelets activate macrophages to produce endogenous platelet derived growth factor (PDGF) and other growth factors which are responsible for would healing. In chronic wounds, macrophage activation is suppressed which leads to an inappropriate growth factor response causing failure of positive autocrine feedback loop which normally controls the healing process. The regular application of exogenous PRP and Thrombin, to chronic wounds, restores the autocrine feedback loop of tissue repair which appears to accelerate the normal cascade of tissue repair
Objectives
- To evaluate the safety and tolerability of PRP/Thrombin mixture in treating chronic venous ulcers
- To evaluate efficacy of PRP/Thrombin mixture in treating chronic venous ulcers
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give written informed consent
- •Age 18 years to 75 years.
- •Both males and females.
- •Ankle branchial index of 0.8 or above.
排除标准
- •Diabetics will be excluded as the Ankle Branchial Index (ABI) result is considered an unreliable due the possible presence of arteriosclerotic plaques (lead pipe rigidity).
- •Patients who have participated in experimental drug studies within 30 days of entering this study.
- •receiving chemotherapy or radiotherapy for malignant diseases or any other indication
- •Patients taking corticosteroids or other immunosuppressive medications
- •Clinically malnourished patients or those with recent (last 4 weeks without treatment) serum albumin of less than 30g/l.
- •Patients with current or past history of acute deep vein thrombosis.
- •Patients with current signs and/or symptoms of cardiac, renal or hepatic failure. Renal failure defines as Creatinine
- •Patients with signs and/or symptoms of peripheral neuropathy.
- •Patients with signs and/or symptoms of ATROPHIE BLANCHE or other conditions associated with non-chronic venous insufficiency ulceration of the lower leg.
- •Patients with signs and/or symptoms of immunocompromized sates or recent (last 4 weeks ) T cell subset (CD4) count of less than 200 cells / ml.
- •Patients showing clinical signs and/or symptoms of anaemia or current or recent(last 4 weeks without treatment) haemoglobin level of less than 8g/dl
研究组 & 干预措施
Treatment arm
Subjects receiving the study drug which is PRP/thrombin mixture
干预措施: PRP/thrombin mixture (Drug)
结局指标
主要结局
Number and type adverse events
时间窗: 12 weeks
Adverse events will reported at the start and throughout the treatment period
Size of the wound treated with the PRP/thrombin mixture
时间窗: 12 weeks
Size of the wound will be measured at the end of the study
次要结局
未报告次要终点
研究者
Johnny Mahlangu
Professor
University of Witwatersrand, South Africa