Topical treatment of XXXX with platelet-derived growth factor-BB: a randomized controlled trial.

@entity1 @entity101 @entity1066 @entity35745 @entity158
OBJECTIVE: To determine the healing effect of topical becaplermin gel vs hydrogel dressing on @entity101 . DESIGN: Randomized, double-blind, parallel-assignment, controlled study. SETTING: Ambulatory or hospitalized @entity1 from 17 dermatology departments. @entity1 : Among 64 consecutive randomized @entity1 with 1 or more @entity101 who fulfilled all inclusion criteria, 59 received the allocated intervention, and findings were analyzed. INTERVENTION: Becaplermin gel ( @entity1 recombinant platelet-derived growth factor-BB, 0.1%, in hydrogel) or hydrogel dressing was applied, both in doses of 1 cm/cm(2), once daily for 8 weeks. Follow-up continued for 4 weeks beyond the final gel application. MAIN OUTCOME MEASURES: The primary end point was complete wound closure rate after 8 weeks of treatment. Secondary end points were percentages of @entity1 with complete wound closure at week 12; changed @entity1066 area after treatment vs baseline; and changed @entity1066 -related @entity158 and health-related quality of life during the study. RESULTS: Complete wound closure rates were comparable after 8 weeks for @entity35745 (5 of 28 @entity1 ) and hydrogel (3 of 31 @entity1 ) (8 percentage-point difference; 95% confidence interval, -10% to 26%). No statistically significant differences were observed between the 2 groups for percentages of complete closure at week 12, changed @entity1066 area at week 8, or changed @entity1066 -related @entity158 and quality of life during the study (P > .05 for all comparisons). CONCLUSIONS: Topical becaplermin gel is not superior to hydrogel dressing for @entity101 leg @entity1066 wound closure. Surgical management by grafting remains the most promising treatment strategy but requires further evaluation. Trial Registration clinicaltrials.gov Identifier: NCT00970697.
