title: Topical treatment of hypertensive leg ulcers with platelet-derived growth factor-BB: a randomized controlled trial.
abstract: OBJECTIVE
  To determine the healing effect of topical becaplermin gel vs hydrogel dressing on hypertensive leg ulcers.
  
  
  METHODS
  Randomized, double-blind, parallel-assignment, controlled study.
  
  
  METHODS
  Ambulatory or hospitalized patients from 17 dermatology departments.
  
  
  METHODS
  Among 64 consecutive randomized patients with 1 or more hypertensive leg ulcers who fulfilled all inclusion criteria, 59 received the allocated intervention, and findings were analyzed.
  
  
  METHODS
  Becaplermin gel (human 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.
  
  
  METHODS
  The primary end point was complete wound closure rate after 8 weeks of treatment. Secondary end points were percentages of patients with complete wound closure at week 12; changed ulcer area after treatment vs baseline; and changed ulcer-related pain and health-related quality of life during the study.
  
  
  RESULTS
  Complete wound closure rates were comparable after 8 weeks for becaplermin (5 of 28 patients) and hydrogel (3 of 31 patients) (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 ulcer area at week 8, or changed ulcer-related pain and quality of life during the study (P > .05 for all comparisons).
  
  
  CONCLUSIONS
  Topical becaplermin gel is not superior to hydrogel dressing for hypertensive leg ulcer wound closure. Surgical management by grafting remains the most promising treatment strategy but requires further evaluation. Trial Registration clinicaltrials.gov Identifier: NCT00970697.
authors.affiliation: Service de Dermatologie, Hôpital Tenon, 4 rue de la Chine, 75970 Paris CEDEX 20, France. patricia.senet@tnn.aphp.fr.
authors.forename: Patricia
authors.initials: P
authors.lastname: Senet
authors.forename: Eric
authors.initials: E
authors.lastname: Vicaut
authors.forename: Nathalie
authors.initials: N
authors.lastname: Beneton
authors.forename: Clelia
authors.initials: C
authors.lastname: Debure
authors.forename: Catherine
authors.initials: C
authors.lastname: Lok
authors.forename: Olivier
authors.initials: O
authors.lastname: Chosidow
mesh_terms: D000368:Aged; D000077214:Becaplermin; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications; D007871:Leg Ulcer / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D010982:Platelet-Derived Growth Factor / Q000627:therapeutic use*; D020574:Proto-Oncogene Proteins c-sis
chemical_list: D010982:Platelet-Derived Growth Factor; D020574:Proto-Oncogene Proteins c-sis; D000077214:Becaplermin