Non-Healing Ulcers Without Critical Limb Ischemia (NEWLI)
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.
Peripheral Artery Disease Without Critical Limb Ischemia
Procedure: Angioplasty of the lower limbs vessels
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Ulcer healing [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
1) Procedural efficacy: efficacy will be evaluated according to clinical and para-clinical parameters:
a. Clinical efficacy: i. ulcer heal or improvement at 6 months; ii. avoidance of minor (i.e. toe or for-foot) or major (i.e. below or above the knee) amputations; iii. improvement of the ulcer-related pain:
1. The ulcer-related pain will be evaluated with the use of the Borg visual assist scale (Borg VAS) before, at 1 week, 1-3-6 months after the procedure.
iv. Improvement of the ulcer size:
1. The ulcer size will be recorded by measurements and photographic records before, at 1 week, 1-3-6 months after the procedure.
v. The number of skin grafts necessary to heal the ulcer will be recorded and compared to the number of the skin grafts which have failed to heal the ulcer in the pre-revascularization period.
- Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Para-clinical efficacy: improvement of the ABI, TP, tcPO2 values at 1 week, 1-3-6 months after the procedure.
- Procedural success, defined as a successful endovascular revascularization procedure, in all consecutive patients according to the inclusion and exclusion criteria = technical feasibility.
- Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]3) Procedural safety, defined as the proportion of procedures performed in the absence of any procedural-related complications (= safety).
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
patients will revascularized after a conservative treatment failure of at least 4 weeks
Procedure: Angioplasty of the lower limbs vessels
Standard revascularization techniques will be used in the study
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666093
|Contact: Robert F Bonvini, MD||0041 22 372 72 firstname.lastname@example.org|
|Contact: Neda Badaoui-Barouti, MD||0041 22 372 33 email@example.com|
|Angiology and Dermatology Divisions / HUG||Recruiting|
|Geneva, Switzerland, 1211|
|Contact: Robert F Bonvini, MD 0041 22 372 72 00 firstname.lastname@example.org|
|Principal Investigator: Robert F Bonvini, MD|