Outcomes of Endovascular Revascularization in CLTI in Patients Associated With Heel Ulcers
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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)
Study Design
Outcome Measures
Primary Outcome Measures
- Treatment success [1 year]
residual diameter stenosis of less than 30% at the end of the procedure as demonstrated on completion angiography
- Procedural complications [1 year]
according to the society of intervention radiology (SIR) criteria.
Secondary Outcome Measures
- Primary patency [1 year]
freedom from clinically driven target lesion revascularization (CD-TLR) and restenosis (DUS peak systolic velocity ratio >2.5
- CD-TLR [1 year]
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
- Amputation free survival (AFS) [1 year]
s time until a major (above-ankle) amputation of the index limb or death from any cause.
Eligibility Criteria
Criteria
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:
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Patients with arterial thrombosis , dissection, or embolism.
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Known intolerance to the study medications or contrast agents
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Patients with failing or failed bypass grafts
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Butt T, Lilja E, Orneholm H, Apelqvist J, Gottsater A, Eneroth M, Acosta S. Amputation-Free Survival in Patients With Diabetes Mellitus and Peripheral Arterial Disease With Heel Ulcer: Open Versus Endovascular Surgery. Vasc Endovascular Surg. 2019 Feb;53(2):118-125. doi: 10.1177/1538574418813746. Epub 2018 Nov 22.
- Linn YL, Chan SL, Soon SXY, Yap CJQ, Lim MNHH, Lee QWS, Chong TT, Tang TY. Heal or no heel: Outcomes of ischaemic heel ulcers following lower limb revascularization from a multi-ethnic Asian Cohort in Singapore. Int Wound J. 2020 Dec;17(6):2010-2018. doi: 10.1111/iwj.13493. Epub 2020 Aug 24.
- Endovascular revascularization