Becaplermin Gel for MARTORELL's Hypertensive Leg Ulcers

Summary

Background: No medical treatment has proved its efficacy for the treatment of hypertensive leg ulcers in a well designed trial. Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated with becaplermin gel (Regranex Gel®) daily application versus the application of the same quantity of an hydrogel (Duoderm Hydrogel™), corresponding to the excipient of becaplermin gel. Method: Ambulatory or hospitalized patients presenting with an hypertensive leg ulcer, were randomized to receive either a daily application of becaplermin gel or hydrogel during 8 weeks. At week 8, a pinch graft was proposed to patients whom the ulcer has not healed. Primary aim of the study: Complete closure at week 8 Secondary aims: percentage of wound area reduction at week 8, complete closure at week 12, pain and quality of life during treatment Study hypothesis: becaplermin gel may promote the healing of hypertensive leg ulcers and be an alternative medical treatment to the skin graft usually proposed

Timeline

Start

2004-01

Primary completion

2009-05

Completion

2009-06

Publications

• Senet P, Vicaut E, Beneton N, Debure C, Lok C, Chosidow O. Topical treatment of hypertensive leg ulcers with platelet-derived growth factor-BB: a randomized controlled trial. Arch Dermatol. 2011 Aug;147(8):926-30. doi: 10.1001/archdermatol.2011.84. Epub 2011 Apr 11.

Drugs

Indications