Becaplermin Gel for MARTORELL's Hypertensive Leg Ulcers

PHASE3CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

May 31, 2009

Study Completion Date

June 30, 2009

Conditions
MARTORELL'S ULCERHypertensive Leg UlcerNecrotic Angiodermatitis
Interventions
DRUG

becaplermin gel

the amount of the gel to be applied was determined based on ulcer area at inclusion and remains identical during all the treatment The posology was identical to what is recommended for Regranex gel®: a single 15g-tube is enough to treat a 5 cm2-wound during 6 weeks (1 cm of gel is applied daily for 5 cm2) Wound was then recovered by a moist saline gauze and a bandage. Becaplermin gel is packaged into masked 15g-tubes.

DRUG

Duoderm Hydrogel™

The amount of the gel to be applied was determined based on ulcer area at inclusion, and remains identical during all the treatment. The posology was identical to what is recommended for Regranex gel®: a single 15g-tube is enough to treat a 5 cm2-wound during 6 weeks (1 cm of gel is applied daily for 5 cm2) Wound was then recovered by a moist saline gauze and a bandage. Hydrogel dressing is identical in appearance, color, consistency, and odor than becaplermin gel, and packaged in similar masked15g-tubes.

Trial Locations (1)

Unknown

Hospital Charles Foix, Ivry-sur-Seine

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT00970697 - Becaplermin Gel for MARTORELL's Hypertensive Leg Ulcers | Biotech Hunter | Biotech Hunter