Becaplermin Gel for MARTORELL's Hypertensive Leg Ulcers

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 1, 2009

Keywords

ClinConnect Summary

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 diabetes. Healing takes a mean of 4 to 12 months. Current treatment is difficult and usually surgical (pinch or meshed skin grafts). Growth factors release by autografted skin may be a significant factor in the promotion of hypertensive leg ulcer healing. Recombinant human platelet derived growth-factor-BB gel (becaplermin gel) has been shown to be effective in the treatment of diabetic ulcers rela...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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