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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Complete wound closure rate at week 8 of treatment
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: becaplermin gel (Drug)
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.
干预措施: Duoderm Hydrogel™ (Drug)
结局指标
主要结局
Complete wound closure rate at week 8 of treatment
时间窗: week 9
次要结局
- Complete wound closure rate at week 12 of treatment(week 13)
- pain and quality of life evolution during the treatment( W4,8,10,12),(week 9)
- % of wound area reduction at week 8 and 12(weeks 9 and 13)
- safety of the treatment at week 4, 8 and 12(week 13)