| Methods |
Method of randomisation: states randomisation but no description
Assessor blinding: yes
Intention to treat: withdrew patients if hospitalised or non‐compliant
Lost to follow‐up: intervention 8 (withdrawn excluding 1 death); control 3 (withdrawn excluding 1 death)
Timing of the intervention: daily for 6 months taken between meals
Length of follow‐up: 2 years |
| Participants |
Location: Dept of Internal Medicine, Lund University Hospital, Sweden
53 patients
Inclusion criteria: patients over 60 years with diabetes mellitus and a Wagner grade or 2 foot ulcer over 4 weeks duration, distal blood pressure measured in the last 3 months |
| Interventions |
a: 400 ml Fortimel (1 kcal/ml Nutricia AB, Netherlands) b: 400 ml placebo Allocated: 26/27
Assessed: 17/23 |
| Outcomes |
Main outcomes: Mortality, wound healing, amputations, nutritional status, compliance Additional outcomes: wound healed at 6 months, amputations |
| Notes |
No description of allocation concealment |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
