Outcomes of Endovascular Revascularization in CLTI in Patients Associated With Heel Ulcers

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

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

Conditions
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Lower Limb Ischemia Critical

Intervention / Treatment
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* Procedure: C-arm device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients with arterial thrombosis , dissection, or embolism. Known intolerance to the study medications or contrast agents Patients with failing or failed bypass grafts

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: C-arm device|Percutaneous Transluminal Angioplasty|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success | residual diameter stenosis of less than 30% at the end of the procedure as demonstrated on completion angiography | 1 year | 
| Procedural complications | according to the society of intervention radiology (SIR) criteria. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | freedom from clinically driven target lesion revascularization (CD-TLR) and restenosis (DUS peak systolic velocity ratio >2.5 | 1 year | 
| CD-TLR | any re-intervention at the target lesion(s) due to symptoms or drop of ABI of ≥20% or >0.15 when compared to post-procedure baseline ABI | 1 year | 
| Amputation free survival (AFS) | s time until a major (above-ankle) amputation of the index limb or death from any cause. | 1 year |