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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Sulodexide effect on walking ability in patients with intermittent claudication
Scientific title
Sulodexide effect on intermittent claudication in patients presenting Fontaine stage II peripheral arterial occlusive disease
Secondary ID [1] 262574 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intermittent claudication 268291 0
Peripheral arterial occlusive disease 268292 0
Condition category
Condition code
Cardiovascular 268369 268369 0 0
Diseases of the vasculature and circulation including the lymphatic system

Study type
Description of intervention(s) / exposure
sulodexide at the dose of 100 mg daily (two 25 mg capsules twice a day) for a period of one month.
Intervention code [1] 266939 0
Treatment: Drugs
Comparator / control treatment
placebo: two sugar pills capsules twice a day for a period of one month.
Control group

Primary outcome [1] 269178 0
Initial claudication distance ratio (ICDr), defined as the ratio of post-treatment to pre-treatment pain-free walking distance tolerated by the patient
Timepoint [1] 269178 0
at one month
Secondary outcome [1] 279043 0
Peripheral hemodynamics changes measured by ankle brachial index
Timepoint [1] 279043 0
at one month
Secondary outcome [2] 279044 0
Subjective evaluation of the walking impairment (walking impairment questionnaire)
Timepoint [2] 279044 0
at one month
Secondary outcome [3] 279073 0
- Subjective evaluation of the quality of life expressed on an arbitrary score:
0: absence of subjective symptoms (pain, cramps, numbness, burning sensation, fatigue)
1: tolerable subjective symptoms not interfering with daily life activities
2: moderate subjective symptoms limiting daily activities
3: severe and disabling subjective symptoms
Timepoint [3] 279073 0
at one month

Key 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
Minimum age
30 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
Key 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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 3700 0
State/province [1] 3700 0

Funding & Sponsors
Funding source category [1] 267412 0
Self funded/Unfunded
Name [1] 267412 0
Georges Tabet
Address [1] 267412 0
Hotel Dieu de France Hospital
Alfred Naccache Street
Achrafieh, Beirut
Country [1] 267412 0
Primary sponsor type
Georges Tabet
Hotel Dieu de France Hospital
Alfred Naccache Street
Achrafieh, Beirut
Secondary sponsor category [1] 266467 0
Name [1] 266467 0
Address [1] 266467 0
Country [1] 266467 0

Ethics approval
Ethics application status
Ethics committee name [1] 269356 0
Ethical committee of Hotel Dieu de France Hospital
Ethics committee address [1] 269356 0
Ethics committee country [1] 269356 0
Date submitted for ethics approval [1] 269356 0
Approval date [1] 269356 0
Ethics approval number [1] 269356 0

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 32835 0
Address 32835 0
Country 32835 0
Phone 32835 0
Fax 32835 0
Email 32835 0
Contact person for public queries
Name 16082 0
Georges Tabet
Address 16082 0
Hotel Dieu de France Hospital
Alfred Naccache Street
Achrafieh, Beirut
Country 16082 0
Phone 16082 0
+961 1 612662
Fax 16082 0
Email 16082 0
Contact person for scientific queries
Name 7010 0
Georges Tabet
Address 7010 0
Hotel Dieu de France Hospital
Alfred Naccache Street
Achrafieh, Beirut
Country 7010 0
Phone 7010 0
+961 1 612662
Fax 7010 0
+961 1 612663
Email 7010 0

No information has been provided regarding IPD availability
Summary results
No Results