NCT03370705

Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Treatment (CT) Vs CT Alone

A Multicentric Open-label Randomized Controlled Study for Evaluating the Improvement of Endothelial Function in Stage II Peripheral Arterial Obstructive Disease Patients Treated With Sulodexide + Conventional Treatment {CT] Vs CT Alone

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Alfa Wassermann Tunisia · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Peripheral Arterial Obstructive Disease

Interventions

Type	Name	Description
DRUG	Sulodexide	Sulodexide 250 ULS twice daily per oral route
DRUG	Statin	Statin 20mg once daily per oral route,
DRUG	Antiplatelet Agents	Antiplatelet therapy 75mg once daily per oral route
DRUG	ACE inhibitor	ACE inhibitor 20mg once daily per oral route

Timeline

• Start date: 2019-01-31
• Primary completion: 2019-12-30
• Completion: 2020-03-30
• First posted: 2017-12-12
• Last updated: 2019-12-02

Locations

3 sites across 1 country: Tunisia