Peripheral Artery Disease Without Critical Limb Ischemia Clinical Trial
Official title:
NON-HEALING ULCERS WITHOUT CRITICAL LIMB ISCHEMIA (NEWLI-Trial): A Single Center Pilot Trial on the Efficacy of an Endovascular Approach for Treatment of Non-healing Lower Limb Ulcers in Patients Presenting With a Mild to Moderate Peripheral Artery Disease
Background: Lower limb arterial revascularization procedures, either percutaneously or
surgically performed, are an established treatment modality of ischemic foot ulcers,
especially in the setting of a critical limb ischemia. Many other lower limb ulcers are
secondary to a combined disease, which may include a concomitant venous disease (chronic
venous insufficiency or varicous disease) or a micro-angiopathic disease (i.e. small vessel
disease). In this setting, and especially in the absence of a concomitant severe
macro-angiopathic disease, the safety and efficacy of a percutaneous lower limb
revascularization have so far never been evaluated in a prospective study.
Aim: This study is aimed to evaluate the safety and the efficacy of an endovascular
revascularization approach of the lower limb, in all consecutive patients presenting with a
non-healing ulcer associated with a mild to moderate peripheral artery disease (i.e.
mixed-origin ulcers).
Material and methods: This prospective study will consecutively include all patients
presenting with a non-healing ulcer. Included patients must have all the concomitant ulcer
co-factors being adequately treated for at least 6 months. Accordingly, an underlying venous
disease, infectious disease or inflammatory disorder must be previously evaluated and
adequately treated (i.e. compression stocking, varices stripping, antibiotics, local ±
systemic anti-inflammatory, etc.). Furthermore, a non-invasive arterial evaluation must be
obtained in all patients. The arterial screening must included an ankle-brachial index (ABI)
and toe pressure (TP) measurements, a trans-cutaneous oxygen measurement (tcPO2) at the foot
and calf levels and a non-invasive arterial mapping (i.e. angio-CT or angio-MRI). This
arterial work-up must be compatible with the presence of a mild to moderate peripheral
artery disease without any sign or criteria suggesting the presence of a critical limb
ischemia.
End-points: The success rate of perform an endovascular revascularization intervention in
all consecutive patients which qualify according to the inclusion criteria (technical
feasibility). Establish the proportion of procedural related complications (safety). Analyze
the clinical and the para-clinical improvements in term of heal of the ulcers, as well as
the improvement of the ABI, TP, tcPO2 at 1 week, 1-3-6 months after the procedure
(efficacy).
Sample size: The investigators plan to include ≈ 30 patients in two years. After 1 year of
enrollment the investigators will perform an interim analysis and will decide at that
moment, according to the observed end-points, if prolonging the study would be of any
scientific value or if the study has to be interrupt earlier because of a significant
improvement of all already treated ulcers.
see above ;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment