Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05570968
Enrollment
100
Registered
2022-10-07
Start date
2022-10-31
Completion date
2023-10-31
Last updated
2022-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Ischemia Critical

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)

Interventions

PROCEDUREC-arm device

Percutaneous Transluminal Angioplasty

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment success1 yearresidual diameter stenosis of less than 30% at the end of the procedure as demonstrated on completion angiography
Procedural complications1 yearaccording to the society of intervention radiology (SIR) criteria.

Secondary

MeasureTime frameDescription
Primary patency1 yearfreedom from clinically driven target lesion revascularization (CD-TLR) and restenosis (DUS peak systolic velocity ratio \>2.5
CD-TLR1 yearany 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 years time until a major (above-ankle) amputation of the index limb or death from any cause.

Contacts

Primary ContactYehia Mohamed Abdelhadi, PHD
yehiamohamed96@yahoo.com+201147571718
Backup ContactMostafa Mohamed Elmohrezy, MD
el_mohrezy@hotmail.com+201003713399

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026