| Methods |
Study design: double blind, randomised, placebo‐controlled trial.
Method of randomisation: not stated.
Concealment of allocation: supplied by manufacturer.
Exclusions post randomisation: none.
Losses to follow up: none.
Intention to treat: not stated |
| Participants |
Country: Italy.
Setting: hospital outpatient department.
No: 30.
Age: (mean) 58, range 40 to 72 years.
Sex: males 20; females 10.
Inclusion criteria: multi‐sited atherosclerosis confirmed by Doppler.
Exclusion criteria: patients with severe liver disease, and severe endocrine dysfunction. |
| Interventions |
Treatment: one vial of sulodexide (300 LSU) twice daily i.m. for 10 days followed by 2 sulodexide capsules (150 LSU) twice daily for 80 days.
Control: identical placebo
Duration: 90 days. |
| Outcomes |
Total walking distance; subjective parameters (night pain intensity, cramps, tingling, burning, sense of coldness in lower limbs) confirmed using Doppler.
Subjective parameters were confirmed using Doppler. |
| Notes |
Biochemical and haematologcial outcomes measured pre, during, and post study. Active treatment associated with reduced tChol and VLDL and increased HDL. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
