Status:
COMPLETED
Becaplermin Gel for MARTORELL's Hypertensive Leg Ulcers
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
MARTORELL'S ULCER
Hypertensive Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 hypertensiv...
Detailed Description
Hypertensive leg ulcers are a variety of leg ulcer characterized by very painful and spreading lesions, related to cutaneous microangiopathy, occurring in patients presenting hypertension and /or diab...
Eligibility Criteria
Inclusion
- patients 18 years of age or older, able to give informed consent and to follow the treatment procedure
- target ulcer area between 1 and 30 cm2
- consecutive patients presenting with one or more leg ulcers diagnosed as hypertensive MARTORELL's ulcers
- presence of an arterial hypertension, according to the WHO criteria, treated or not; and/or presence of a diabetes treated by oral agent, insulin or diet
- absence of clinical signs of chronic venous insufficiency: skin hyperpigmentation, lipodermatosclerosis
- absence of significant peripheral arterial occlusive disease: presence of peripheral pulses or ankle brachial index ≥0.8
- absence of clinical sign of arterial insufficiency: intermittent claudication, resting pain
- superficial spreading necrotic ulcer
- presence of spontaneous pain
- presence of a red purpuric margin
Exclusion
- pregnancy
- allergy to hydrogel or to becaplermin gel
- uncontrolled or evolving systemic disease: cardiac or renal failure, hepatic insufficiency, malignant disease, thrombotic disease, vasculitis or other connective tissue disorder
- presence of a cryoglobulinemia
- serum creatinine concentration greater than 200µmol/L or uncontrolled diabetes (fasting blood glucose \> 2,5 g/L under treatment)
- concomitant treatment by ILOMEDINE
- bone, joint or tendon (except for achilles tendon) exposition in the wound
- systemic treatment with corticosteroid agents or cytotoxic drugs in the past 3 months before inclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00970697
Start Date
January 1 2004
End Date
June 1 2009
Last Update
October 4 2011
Active Locations (1)
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1
Hospital Charles Foix
Ivry-sur-Seine, Île-de-France Region, France