Becaplermin Gel for MARTORELL's Hypertensive Leg Ulcers (ERAN)

• Complete wound closure rate at week 8 of treatment [ Time Frame: week 9 ] [ Designated as safety issue: No ]
  

• Complete wound closure rate at week 12 of treatment [ Time Frame: week 13 ] [ Designated as safety issue: No ]
  
• pain and quality of life evolution during the treatment( W4,8,10,12), [ Time Frame: week 9 ] [ Designated as safety issue: No ]
  
• % of wound area reduction at week 8 and 12 [ Time Frame: weeks 9 and 13 ] [ Designated as safety issue: No ]
  
• safety of the treatment at week 4, 8 and 12 [ Time Frame: week 13 ] [ Designated as safety issue: Yes ]
  

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 related to diabetic microangiopathy. The objective of the study was to assess the efficacy of becaplermin gel for the healing of hypertensive leg ulcers. Study design: prospective, randomized, multi-centre, double blind, controlled, parallel groupPrimary aim: complete wound closure at week 8Secondary aims: complete wound closure at week 12, pain and quality of life assessment during the treatment( W4,8,10,12), % of wound area reduction at week 8 and 12 Method: Inclusion of 64 patients, 32 in each group. The study population consisted of consecutive patients presenting with one or more leg ulcers diagnosed as hypertensive MARTORELL's ulcers: hypertensive and/or diabetic patients, in absence of chronic venous insufficiency (C5-C6 of the CEAP) or peripheral arterial occlusive disease (presence of peripheral pulses or ankle brachial index ≥0.8), superficial spreading necrotic ulcer, presence of spontaneous pain, and presence of a red purpuric margin. Treatment consists of a daily application of a continuous thin layer of becaplermin gel (Regranex Gel®) or Duoderm Hydrogel™, during 8 weeks. The amount of the gel to be applied was determined based on ulcer area at inclusion (as recommended for Regranex gel®), and remains identical during all the treatment. Wound was then recovered by a moist saline gauze and a bandage. Duoderm Hydrogel™ is a sodium carboxymethylcellulose aqueous-based gel, similar in composition to becaplermin excipient.At week 8, a pinch graft was proposed to patients whom the ulcer was not healed. Between weeks 8 and 12, if patient had not healed and was not grafted, dressing was chosen by the investigator, depending on the wound stage. All patients were followed until week 12.