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临床试验/NCT07488637
NCT07488637尚未招募不适用

Impact of Woundsome Revascularization on the Outcomes of Endovascular Intervention in Patients With Chronic Limb-Threatening Ischemia

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Limb Salvage

研究概览

简要总结

Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease and remains a major health problem. Although the angiosome concept was introduced to guide revascularization by restoring direct blood flow to the affected tissue, its usefulness is limited by anatomical variations, collateral circulation, and wounds involving multiple territories. The emerging "woundsome" concept focuses instead on improving arterial perfusion directly to the wound area, recognizing that both direct revascularization and effective collateral circulation can contribute to successful limb salvage and wound healing.

详细描述

Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of lower-extremity peripheral artery disease (PAD) and is a major global health concern with escalating prevalence and significant health-care costs. Fortunately, technological advancements, evolving revascularization strategies, as well as refinement and expansion of the skill set of surgical and endovascular specialists have successfully reduced the number of patients previously deemed inappropriate for revascularization. The recent Global Vascular Guidelines on the management of CLTI acknowledge limitations about incorporating the terminal circulation into its algorithmic framework. In 2006, Attinger et al introduced the concept of the 6 Angiosomes in the foot and ankle, originating from the 3 main infrapopliteal arteries, as a dependable method to guide revascularization procedures and ensure direct blood flow to trophic lesions. However, doubts about the utility of the "Angiosome" concept have emerged over time. One significant limitation lies in its reliance on standard anatomy, disregarding potential anatomical variations, possible collateralized vessel contributions, such as from peroneal artery branches supplying anterior and/or posterior circulation patterns, and the role of a patent and non-significantly diseased pedal arch. In addition, the frequent involvement of more than one angiosome in cases of larger wounds clouds its application. Here comes the concept "Woundsome," a term that encapsulates the dynamic impact of increasing the direct arterial blood flow to the wound area in patients with Chronic Limb-Threatening Ischemia (CLTI) and tissue loss. Existing literature focusing on CLTI patients with tissue loss has consistently indicated that the presence of direct arterial flow to the wound is associated with superior outcomes in terms of limb salvage and wound healing. Conversely, the presence and quality of foot collaterals following indirect revascularization procedures have also shown to be important in predicting clinical success, often yielding results comparable to direct revascularization.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Patients with CLTI with tissue loss (Rutherford Class 5 or 6 8, 9, or WIFI stage 2-4 10).
  • 2. Patients with Infrapopliteal Arterial Occlusions requiring revascularization

排除标准

  • Patients with Unsalvagble Limbs.
  • Patients with Acute Limb Ischemia (ALI).
  • Patients with Non Atherosclerotic diseases as Vasculitis including large vessel vasculitis (e.g., Giant Cell Arteritis, Takayasu's Arteritis), medium vessel vasculitis (e.g., Polyarteritis Nodosa, Kawasaki disease), and small vessel vasculitis (e.g., Granulomatosis with Polyangiitis, Microscopic Polyangiitis). Other types include Behçet's disease, Buerger's disease.
  • 3. Patients with Contraindications to Contrast Medium.
  • Patients with Aortoiliac or Femoropopliteal (FP) Occlusive disease.

结局指标

主要结局

Limb Salvage

时间窗: Limb salvage will be assessed during follow-up for 12 months after woundsome revascularization. All patients will be scheduled for follow-up visits every 6 months for 1 year (0, 6, 12 months)

To assess the rate of limb salvage following woundsome-guided revascularization in patients with chronic limb-threatening ischemia.

次要结局

未报告次要终点

研究者

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

Andrew Wageeh Latif

Resident Doctor

Assiut University

研究点 (1)

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