Becaplermin Gel for MARTORELL's Hypertensive Leg Ulcers (ERAN)
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|ClinicalTrials.gov Identifier: NCT00970697|
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : October 4, 2011
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
|Condition or disease||Intervention/treatment||Phase|
|MARTORELL'S ULCER Hypertensive Leg Ulcer Necrotic Angiodermatitis||Drug: becaplermin gel Drug: Duoderm Hydrogel™||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Double Blind Randomized Controlled Trial of Recombinant Human Platelet Derived Growth Factor-BB Gel (Regranex Gel®) Versus Hydrogel (Duoderm Hydrogel®) for Healing of MARTORELL's Hypertensive Leg Ulcers. ERAN Trial.|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||June 2009|
Experimental: becaplermin gel
application of a continuous thin layer of becaplermin gel (Regranex Gel®) during 8 weeks. The amount of the gel to be applied was determined based on ulcer area at inclusion, and remains identical during all the treatment.
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.
Active Comparator: Duoderm Hydrogel™
application of a continuous thin layer of hydrogel dressing (Duoderm Hydrogel®), during 8 weeks. Duoderm Hydrogel™ is a sodium carboxymethylcellulose aqueous-based gel, similar in composition to becaplermin excipient.
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.
- Complete wound closure rate at week 8 of treatment [ Time Frame: week 9 ]
- Complete wound closure rate at week 12 of treatment [ Time Frame: week 13 ]
- pain and quality of life evolution during the treatment( W4,8,10,12), [ Time Frame: week 9 ]
- % of wound area reduction at week 8 and 12 [ Time Frame: weeks 9 and 13 ]
- safety of the treatment at week 4, 8 and 12 [ Time Frame: week 13 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970697
|Hospital Charles Foix|
|Ivry sur seine, Ile de France, France|
|Principal Investigator:||Patricia SENET||Dermatology, Charles Foix|