Comparison of the two most commonly used treatments for XXXX : results of the STOP GAP randomised controlled trial.

@entity1 @entity32 @entity6794 @entity1066 @entity205 @entity281 @entity158 @entity272 @entity617
OBJECTIVE: To determine whether @entity205 is superior to @entity617 for the treatment of @entity6794 , a @entity158 , ulcerating @entity272 with a poor evidence base for management. DESIGN: Multicentre, parallel group, observer blind, randomised controlled trial. SETTING: 39 UK hospitals, recruiting from June 2009 to November 2012. @entity1 : 121 @entity1 (73 @entity1 , mean age 54 years) with clinician diagnosed @entity6794 . Clinical diagnosis was revised in nine @entity1 after randomisation, leaving 112 @entity1 in the analysis set (59 @entity205 ; 53 @entity617 ). INTERVENTION: Oral @entity617 0.75 mg/kg/day compared with @entity205 4 mg/kg/day, to a maximum dose of 75 and 400 mg/day, respectively. MAIN OUTCOME MEASURES: The primary outcome was speed of healing over six weeks, captured using digital images and assessed by blinded investigators. Secondary outcomes were time to healing, global treatment response, resolution of @entity32 , self reported @entity158 , quality of life, number of treatment failures, adverse reactions, and time to recurrence. Outcomes were assessed at baseline and six weeks and when the ulcer had healed (to a maximum of six months). RESULTS: Of the 112 @entity1 , 108 had complete primary outcome data at baseline and six weeks (57 @entity205 ; 51 @entity617 ). Groups were balanced at baseline. The mean (SD) speed of healing at six weeks was -0.21 (1.00) cm(2)/day in the @entity205 group compared with -0.14 (0.42) cm(2)/day in the @entity617 group. The adjusted mean difference showed no between group difference (0.003 cm(2)/day, 95% confidence interval -0.20 to 0.21; P=0.97). By six months, @entity1066 had healed in 28/59 (47%) @entity1 in the @entity205 group compared with 25/53 (47%) in the @entity617 group. In those with healed @entity1066 , eight (30%) receiving @entity205 and seven (28%) receiving @entity617 had a recurrence. Adverse reactions were similar for the two groups (68% @entity205 and 66% @entity617 ), but serious adverse reactions, especially @entity281 , were more common in the @entity617 group. CONCLUSION: @entity617 and @entity205 did not differ across a range of objective and @entity1 reported outcomes. Treatment decisions for individual @entity1 may be guided by the different side effect profiles of the two drugs and @entity1 preference. Trial registration Current Controlled Trials ISRCTN35898459.
