Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000721909
Ethics application status
Approved
Date submitted
5/07/2011
Date registered
12/07/2011
Date last updated
12/07/2011
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
Nil
Universal Trial Number (UTN)
U1111-1122-6394
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

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 3700 0
Lebanon
State/province [1] 3700 0

Funding & Sponsors
Funding source category [1] 267412 0
Self funded/Unfunded
Name [1] 267412 0
Georges Tabet
Country [1] 267412 0
Lebanon
Primary sponsor type
Individual
Name
Georges Tabet
Address
Hotel Dieu de France Hospital
Alfred Naccache Street
Achrafieh, Beirut
Country
Lebanon
Secondary sponsor category [1] 266467 0
None
Name [1] 266467 0
Address [1] 266467 0
Country [1] 266467 0

Ethics approval
Ethics application status
Approved
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
Lebanon
Date submitted for ethics approval [1] 269356 0
Approval date [1] 269356 0
Ethics approval number [1] 269356 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Lebanon
Phone 16082 0
+961 1 612662
Fax 16082 0
Email 16082 0
[email protected]
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
Lebanon
Phone 7010 0
+961 1 612662
Fax 7010 0
+961 1 612663
Email 7010 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.