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临床试验/NCT05570968
NCT05570968尚未招募不适用

Outcomes of Endovascular Revascularization in Patients With Chronic Limb Threatening Ischemia (CLTI) Associated With Heel Ulcers

Assiut University0 个研究点目标入组 100 人开始时间: 2022年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Procedural complications

研究概览

简要总结

The aim of the current study is to assess outcomes of endovascular revascularization of patients with CLTI associated with heel ulcers and identify possible predictors of healing of these ulcers.

详细描述

Peripheral Arterial Disease (PAD) is a progressive disorder characterized by stenosis and/or occlusion of large and medium-sized arteries and affects the lower extremities more commonly than the upper extremity vessels, and may lead to a recurrent fatigue, cramping sensation, or pain that is known as intermittent claudication, which is the most recognized symptomatic subset of lower extremity PAD. (1) Chronic limb threatening ischemia (CLTI) is an advanced form of PAD encompassing rest pain, lower limb ulceration or gangrene. It is associated with significant morbidity, mortality and healthcare resource utilization. (2) The Society for Vascular Surgery (SVS) Lower Extremity Guidelines Committee realized there was a need for a classification system for threatened limbs that encompassed the full spectrum of disease, as all existing classification systems fell short in this regard. So, they created the WIfI (Wound, Ischemia, and foot Infection) Classification System to categorize these three major risk factors leading to amputation. (3) It contains the key limb status elements needed to gauge the severity of limb threat, which enables physicians to predict amputation risk more accurately. (4) Either surgical or endovascular revascularization is the mainstay of therapy for CLTI. The continuous advance in the field of vascular interventional radiology has facilitated angioplasty through the development of low-profile balloon catheters, various small calibre stents, steerable and hydrophilic guide wires, road map facilities, vasodilators, and antiplatelet medication. (5) Heel ulcers in patients with diabetes mellitus (DM) and PAD are hard to heal. Diabetic heel ulcer is a well-known, hard to-heal ulcer and is considered a major risk factor for lower extremity amputation. Presence of foot ischemia, peripheral neuropathy with external trauma, and foot deformities will further increase the risk of amputation, and it is therefore highly likely that a patient with a diabetic heel ulcer with ischemia will have a great benefit from revascularization, especially if together with adequate infection control. (6)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suffering from CLTI associated with heel ulcers who will undergo endovascular revascularization at Assiut university vascular surgery department between August 2022 and November 2023.

排除标准

  • Patients with arterial thrombosis , dissection, or embolism.
  • Known intolerance to the study medications or contrast agents
  • Patients with failing or failed bypass grafts

结局指标

主要结局

Procedural complications

时间窗: 1 year

according to the society of intervention radiology (SIR) criteria.

Treatment success

时间窗: 1 year

residual diameter stenosis of less than 30% at the end of the procedure as demonstrated on completion angiography

次要结局

  • Primary patency(1 year)
  • CD-TLR(1 year)
  • Amputation free survival (AFS)(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yehia Mohamed Mostafa Abdelhadi

Resident

Assiut University

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