| Methods |
Double‐blind, placebo‐controlled randomised trial, allocation concealment unclear, method of random sequence generation not stated.
Run‐in period: none.
Drop‐outs and study withdrawals: none.
Intention‐to‐treat: yes.
Characteristics of study sample: no significant difference between the two groups at baseline. |
| Participants |
Country: Italy, 36 participants (all male).
Age: mean 64 years; diabetes mellitus: 11.
Inclusion criteria: stage II PAOD (clinical, plethysmographic and/or angiographic diagnostic criteria).
Exclusion criteria: severe liver failure, renal insufficiency, cancer, haemorrhagic diathesis, stroke in previous six months, patients taking heparin or haemorheological agents or fibrinolytic drugs of any kind, nicotinic acid derivatives or hypolipidemic drugs. |
| Interventions |
Treatment group: 18 participants:
LMWH 15,000 U s.c. o.d.
Control group: 18 participants:
placebo (provided in prefilled sterile syringes identical to treatment) s.c. o.d.
Duration: six months.
Compliance: not evaluated. |
| Outcomes |
PFWD, MWD, ABI, major and minor bleeding events. |
| Notes |
Bar graphs only provided for PFWD and MWD. Intensity of walking test not stated.
No further data provided by author due to length of time since publication.
Significant increase in MWD reported in treatment group at end of treatment but no comparison with placebo. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
