None listed
Conditions
Brief summary
Sulodexide, a standardized extractive glycosaminoglycans, was recently implicated in the treatment of intermittent claudication. In this current study, we plan to conduct a randomized double blind placebo control study for a period of one month in patients with Fontaine stage II peripheral arterial occlusive disease. This study will cover the effects of sulodexide on walking performance, ankle brachial index and quality of life.
Interventions
sulodexide at the dose of 100 mg daily (two 25 mg capsules twice a day) for a period of one month.
Sponsors
Georges Tabet
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Typical intermittent claudication confirmed by a reduced ankle brachial index (0.7 on the worst leg measured by a Doppler probe) - A maximum initial walking distance between 30 and 500 m measured by a treadmill test - A maximum change in initial walking distance inferior to 25% on two treadmill tests performed before the inclusion of the patients - Stability of the patient conditions for the last month
Exclusion criteria
- An acute deterioration of the patient condition in the last month. - High variability in walking distances, - Illness limiting the exercise capacity: uncontrolled hypertension, angina pectoris, unstable angina, severe cardiac conduction abnormalities, uncontrolled congestive heart failure, respiratory diseases, orthopedic diseases, neurological disorders - History of hypersensitivity to extractive mucopolysaccharides - Severe hemodynamic stenosis of pelvic arteries - Inflammatory vascular diseases (e.g. thromboangeitis, immunoangiopathy, vascular and collagen disorders); - Aneurysm of the abdominal aorta
Outcome results
None listed