Randomized Study Comparing Clinical and Microbiological Efficacy of Timentin Delivered Via Percutaneous Isolated Limb Perfusion (PILP) or Intravenous Infusion in Diabetic Subjects With Moderate to Severe Lower Limb Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Efficacy of Timentin Delivered by PILP Procedure (Treatment Group) Versus Intravenous Delivery (Control Group) at Reducing Microbiological Load in Subjects With Diabetes, and Significant Wound Infection of the Lower Limb.
研究概览
简要总结
The use of the Percutaneous Isolated Limb Procedure (PILP) which enables the use of existing antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes who have a significant lower limb infection and it is deemed that IV antibiotics are needed in order to salvage the limb or life.
详细描述
During the PILP procedure, the circulation of the limb is isolated separately from the general circulatory system thereby enabling the delivery of antibiotics only to the limb. Limb isolation is achieved by creating an "artificial" circuit where catheters are inserted into the major artery and vein of the lower limb.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •M or F subjects 18 - 90 years old
- •Subject has pre-existing diabetes diagnosis
- •Subject has significant infection below the ankle of soft tissue and may include bone, and IV antibiotics are needed in order to salve limb or life
- •Consequence of infected wound would require Std of Care share debridement
- •Subject willing and able to provide written informed consent
- •Subject willing and able to comply with requirements of study protocol including pre-defined follow-up evaluations
- •PROCEDURAL INCLUSION CRITERIA: successful cannulation of the femoral artery and vein and placement of the venous support device
排除标准
- •Allergy to contrast media
- •Known bleeding disorder including thrombocytopenia
- •Recent AMI or elevated Troponin levels within last 30 days
- •Penicillin sensitivity; Timentin sensitivity
- •Female subjects known to be or suspected to be pregnant or lactating
- •Subject unable to comply with instructions; especially to remain supine for duration of recirculation procedure
- •Subjects who have participated in any other clinical trial or taken investigational drug within 30 days of study enrollment
- •The PI determines the subject is not an appropriate subject for the study
- •PROCEDURAL EXCLUSION CRITERIA: Subjects anatomy interferes with or is expected to prohibit successful cannulation of the femoral vessels or placement of the venous support device
- •Known severe proximal femoral artery vascular disease precluding placement of perfusion catheters
研究组 & 干预措施
Treatment Group
The Treatment Group received intravenous Timentin prior to their PILP procedure.
干预措施: Percutaneous Isolated Limb Perfusion (PILP) delivery (Procedure)
Treatment Group
The Treatment Group received intravenous Timentin prior to their PILP procedure.
干预措施: Timentin (Drug)
Control Group
The Control Group received standard dosings of intravenous Timentin plus other standard care.
干预措施: Timentin (Drug)
结局指标
主要结局
Efficacy of Timentin Delivered by PILP Procedure (Treatment Group) Versus Intravenous Delivery (Control Group) at Reducing Microbiological Load in Subjects With Diabetes, and Significant Wound Infection of the Lower Limb.
时间窗: Day 3
Reduction in microbiological load, including assessment of CFU, infection type and antibiotic sensitivity between the two groups over time. To compare the efficacy of Timentin delivered by PILP procedure (Treatment Group) versus intravenous delivery (Control Group) at reducing microbiological load in subjects with diabetes, and significant wound infection of the lower limb.
次要结局
未报告次要终点