| Methods |
Study design: double blind, double‐dummy, randomised, placebo‐controlled trial.
Method of randomisation: not stated.
Concealment of allocation: not stated.
Exclusions post randomisation: not stated.
Losses to follow up: withdrawals 22; 1 not recorded.
Intention to treat: not stated. |
| Participants |
Country: Italy (mulitcentre).
Setting:inpatients and outpatients.
No: 248 randomised, 225 completed the treatment.
Age: (range in years) treatment, 44 to 93; control, 43 to 93.
Sex: treatment, males 124, females 62; control, males 46, females 16.
Inclusion criteria: PAD (Fontaine stage II or III, confirmed by clinical examination and Doppler test).
Exclusion criteria: Severe systemic infections or severe uncompensated hypertension; active gastroduodenal ulcer; recent haemorrhagic stroke; severe neurologic disorders; neoplastic diseases; renal, hepatic, or cardiovascular failure; known hypoersensitivity to extractive mucopolysaccharides; patients with any risk of haemorrhage; receiving fibrinolytic or anticoagulant treatment; and pregnant or breastfeeding women. |
| Interventions |
Treatment: sulodexide, 25 mg capsules twice daily, 50 mg enteric‐coated tablets twic daily, or 100 mg enteric‐coated tablets once daily. Patients in the treatment groups received dummy treatment of the two active treatments not provided for in that particular group.
Control: placebo. Patients received dummy versions of active drug according to the approprioate dosage schedule.
Duration: 90 days. |
| Outcomes |
Doppler analysis, Winsor Index, treadmill test (pain‐free walking distance), side effects. |
| Notes |
Haematological and biochemical analyses performed monthly. Effect on lipids not reported. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
