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

OBJECTIVE

To determine the healing effect of topical becaplermin gel vs hydrogel dressing on hypertensive leg ulcers.

DESIGN

Randomized, double-blind, parallel-assignment, controlled study.

SETTING

Ambulatory or hospitalized patients from 17 dermatology departments.

PATIENTS

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.

INTERVENTION

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.

MAIN OUTCOME MEASURES

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.