A randomized Multicentric open-label controlled trial. The primary objective of the study is to assess the improvement of endothelial function under sulodexide + conventional treatment or conventional treatment alone in patients with Leriche-Fontaine stage II peripheral arterial obstructive disease (systolic ankle brachial index ABI \< 0. 9).
A randomized Multicentric open-label controlled trial. The primary objective of the study is to assess the improvement of endothelial function under sulodexide + conventional treatment (antiplatelet therapy; plus ACE inhibitor; plus Statin in patients with cholesterol total level \> 1,35 g/l) or conventional treatment alone in patients with Leriche-Fontaine stage II peripheral arterial obstructive disease (systolic ankle brachial index ABI \< 0. 9). Criteria for efficacy evaluation are the assessement of the improvement of the Digital Thermal monitoring between base line (day 1) and day 180 measured by Vendys® and the measurement of the correlation between the Digital Thermal monitoring and the following parameters at base line, day 90 and day 180: * Von Willebrand factor blood level. * Clinical assessment as per pain free walking distance and maximum walking distance, as measured by walking machine. * Fibrinogen blood level. Also an assessment of the study medication observance (patient's compliance) will be done. Safety assessment will be done through the collection of the adverse events occurred during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
Sulodexide 250 ULS twice daily per oral route
Statin 20mg once daily per oral route,
Antiplatelet therapy 75mg once daily per oral route
InvSite Poseidon0031
Sfax, Tunisia
InvSite Poseidon 0022
Sousse, Tunisia
InvSite Poseidon0011
Tunis, Tunisia
Change from baseline endothelial function after 6 months
Assess the improvement of the Digital Thermal monitoring measured by Vendys®: evaluation of the improvement of Fingertip Digital Thermal Monitoring (DTM) and the detection of a significant change of the FT2 parameters as per Endothelix discriminative values provided by the manufacturer between day 1 and day 180 (±15 days).
Time frame: between base line (day 1) and day 180
Metric change of the walking distance
Metric variation of the walking distance: Clinical assessment as per pain free walking distance and maximum walking distance, measured by walking machine. A significant change for more than 30% of the walking distance at the assessment point, to consider it an improvement while analysing.
Time frame: base line, day 90 and day 180:
Change in Von Willebrand Factor (VWF) level
Evidence of significant change in VWF level: Serum levels of Von Willebrand Factor will be measured by immunoturbidiometric method. An improvement of the level of VWF blood level by at least 10% in 1st assessment and 30% in last assessment compared to baseline values
Time frame: base line, day 90 and day 180
Assessment of the study medication observance patient's compliance
Compliance will be stated in accordance to the results stated by the patients during remote monitoring at days, 30, 80, 170, and the drug accountability performed by doctors at days 90 and 180. It will be measured in % of the total destined dose expressed in number of intakes and days of treatment.
Time frame: 180 days
Assessment of safety
Safety will be assessed by checklist questioning during visits and remote interactions, investigators will be responsible for collection and notification to the Sponsor and authorities in case of Serious Adverse Events.
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ACE inhibitor 20mg once daily per oral route
Time frame: 180 days