Peripheral Angioplasty as the First Choice Revascularization Procedure to Promote Ischemic Leg Ulcer Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 主要终点
- Number of patients with ulcer healing
研究概览
简要总结
The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the management of ischemic foot ulcers. All consecutive patients presenting with a foot ulcer at the outpatient Vascular surgery clinic of our hospital were evaluated. If non-invasive parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed and a PTA was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short-term and long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients with worsening ulcers after PTA underwent bypass grafting or amputation.
详细描述
The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the management of ischemic foot ulcers.
Methods: All consecutive patients presenting with a foot ulcer at the outpatient Vascular surgery clinic of our hospital were evaluated. Preoperative evaluation included foot pulse assessment, ankle-brachial-index (ABI) and duplex scanning. If non-invasive parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed and a PTA was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short-term and long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients with worsening ulcers after PTA underwent bypass grafting or amputation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed patients with ischemic foot ulcer and
- •patients aged 18 years or older.
排除标准
- •refusal to participate
- •refusal of PTA therapy
- •lesions not amenable to endovascular revascularization by vascular team's consensus based on preinterventional imaging
- •absolute contraindication to contrast media injection, as determined by the investigator
- •uncontrollable coagulopathy
- •unwilling or unable to provide informed consent or return for required follow-up evaluations and
- •previous or concurrent participation in another clinical research study
结局指标
主要结局
Number of patients with ulcer healing
时间窗: 2 years
Number of patients with complete Ischemic leg ulcer healing defined as the complete epithelization of the lesion
次要结局
- Number of participants with Major adverse events(2 years)
- Amputation free survival(2 years)
- Number of patients with 30-day morbidity and mortality(30 days)
- Number of patients requiring re-intervention(2 years)
- Number of patients with all-cause mortality(2 years)
研究者
Izolde Bouloukaki
MD, PhD
University of Crete