Abstract
Objective: To illustrate the benefit of the factorial design in randomized controlled trials of leg ulcers.
Design: A 2 × 2 × 2 factorial design.
Setting: Hospital leg ulcer clinics in Edinburgh and Falkirk.
Patients: Adults with at least one unhealed leg ulcer of determined origin, present for at least 2 months and greater than 1 cm in diameter.
Interventions: Pentoxifylline (Trental) 400 mg, three times daily, versus placebo
Main outcome measure: Complete healing of all ulcers within 24 weeks.
Results: Of 525 patients screened, 200 pure venous ulcers were randomized (58.5% healed by 24 weeks), 45 complex venous ulcers were randomized (57.8% healed) and 41 arterial patients were randomized (excluding bandaging comparisons) (19.5% healed). There were no interactions between treatments.
Conclusion: The factorial design was feasible to administer and allowed three therapeutic questions to be investigated using the same resources as would have been needed to answer a single question.
Design: A 2 × 2 × 2 factorial design.
Setting: Hospital leg ulcer clinics in Edinburgh and Falkirk.
Patients: Adults with at least one unhealed leg ulcer of determined origin, present for at least 2 months and greater than 1 cm in diameter.
Interventions: Pentoxifylline (Trental) 400 mg, three times daily, versus placebo
Main outcome measure: Complete healing of all ulcers within 24 weeks.
Results: Of 525 patients screened, 200 pure venous ulcers were randomized (58.5% healed by 24 weeks), 45 complex venous ulcers were randomized (57.8% healed) and 41 arterial patients were randomized (excluding bandaging comparisons) (19.5% healed). There were no interactions between treatments.
Conclusion: The factorial design was feasible to administer and allowed three therapeutic questions to be investigated using the same resources as would have been needed to answer a single question.
Original language | English |
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Pages (from-to) | 107-112 |
Number of pages | 6 |
Journal | Phlebology |
Volume | 13 |
Issue number | 3 |
DOIs | |
Publication status | Published - 1 Sept 1998 |
Keywords
- randomised controlled trials
- design
- leg ulcers
- dressings
- drug therapy