Clinical trial NCT05570968: Outcomes of Endovascular Revascularization in CLTI in Patients Associated With Heel Ulcers
Official title: Outcomes of Endovascular Revascularization in Patients With Chronic Limb Threatening Ischemia (CLTI) Associated With Heel Ulcers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lower Limb Ischemia Critical
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with chronic limb threatening ischemia associated with heel ulcers Males or Females

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.

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)

Eligibility 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:

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

Primary outcomes:
measure: Treatment success
timeFrame: 1 year
measure: Procedural complications
timeFrame: 1 year
Secondary outcomes:
measure: Primary patency
timeFrame: 1 year
measure: CD-TLR
timeFrame: 1 year
measure: Amputation free survival (AFS)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.