Ischemic Foot Ulcers: Is Intervention Better Than Wound Care Alone? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Primary endpoint: wound healing at 4 weeks and 12 weeks
研究概览
简要总结
You are being asked to take part in this study because your doctor has determined that you have an ischemic foot ulcer. This research study will compare two approved standard of care treatment modalities for the management of ischemic foot ulcers. The ischemic foot ulcer (wound) on your foot is a result of a blocked artery in your leg. The wound can sometimes be healed with wound care alone, which includes dressing changes with creams and removing (debriding) the dead tissue. Alternatively, the significant narrowing or blockage in one of the arteries in your leg can be treated with several endovascular treatment techniques including:
- angioplasty, also called percutaneous transluminal angioplasty (PTA) and/or
- stent placement
- atherectomy
The hypothesis of this study is that early endovascular or surgical intervention in subjects with moderate arterial insufficiency and a non-healing foot ulcer results in a higher overall incidence of wound healing in a significantly shorter period of time.
详细描述
Design:
This study is a single center, prospective, randomized trial evaluating the benefit of endovascular intervention on the healing of ischemic foot ulcers when compared to best wound care alone. The study population will be comprised of subjects with a foot ulcer and non-palpable or diminished pedal pulses. The expected duration of subjects in this trial is 2 years.
Patients will be randomized into two groups:
- Wound Care (group 1)--Best standard wound care with aggressive debridement
- Endovascular Intervention + Wound Care (group 2)--Best standard wound care in combination with endovascular revascularization
Subjects will undergo standard of care evaluation for ischemic foot ulcers. These same evaluations would be performed whether or not the subject was participating in this research study. In the event that a clinically significant event or unanticipated disease or condition is identified, the subject and their doctor will be notified, the investigator, will review the results of the tests and procedures that are standard of care, and the results will become part of the research record. Prior to undergoing randomization, the subject will sign and fully understand an IRB consent form that is HIPAA compliant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject (male or non-pregnant female) must be greater than or equal to 18 years of age
- •Ischemic ulcer of foot present
- •An ankle-brachial index (ABI) of 0.4 to 0.8 or monophasic-biphasic waveforms on pulse volume recordings. (If the subject is diabetic or has renal failure, with incompressible vessels, a toe brachial index of 0.4 to 0.8 is required.)
- •Signed informed consent
排除标准
- •Severe ischemia as defined by advanced gangrene, an ABI of less then or equal to 0.3 and monophasic waveforms on pulse volume recording
- •Advanced renal insufficiency, defined as serum creatinine greater than or equal to 3 mg/dl
- •Absolute contraindication to contrast media, as determined by the investigator
- •Unwilling or unable to provide informed consent or return for required follow-up evaluations.
- •Previous enrollment in this clinical study
- •Concurrent participation in another clinical research study
结局指标
主要结局
Primary endpoint: wound healing at 4 weeks and 12 weeks
时间窗: 4 weeks and 12 weeks
次要结局
- Secondary endpoints: amputation free survival, time to healing, quality of life, major adverse events.(2 years)
研究者
Rabih A. Chaer
Associate Professor of Surgery
University of Pittsburgh