Becaplermin Gel for MARTORELL's Hypertensive Leg Ulcers
Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
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