Randomized, Third-blind, Controlled Trial of Superiority (Versus Sequential Dressings Recommended by the HAS) of an Electrode Dressing (WoundEL® Electrostimulation Device) on the Healing of Venous Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Rate of healed-leg ulcers
研究概览
简要总结
Several studies have suggested that the endogenous electric field and its polarity stimulate the proliferation and migration of epithelial cells and therefore promote wound healing. WoundEL® will reproduce the endogenous electrical current to stimulate all the factors contributing to healing.
Electrostimulation of wounds, including the WoundEL® device, is a therapy listed but not yet reimbursed in France. The aim of this study is to show that the WoundEL® electrostimulation device is superior to the reference treatments recognized by the HAS.
详细描述
Patients with a leg ulcer will be randomized to the "usual treatment" or "WoundEL" group.
The progress of the leg ulcer will be monitored every 2 weeks for 8 weeks or sooner if wound healing occurs. All leg ulcers will be examined at 10 weeks to check for healing or the condition of the leg ulcer if it has not healed. A third-blind party will also assess the ulcer condition at 10 weeks, based on standardized photographs.
The consumption of analgesics, pain and quality of life will be compared in the 2 groups.
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
- Single (Outcomes Assessor)
盲法说明
The third blind person will have photographs of the wound at 10 weeks and all the surface readings on tracing paper necessary for the automated calculation of the surface with specific software. Readings will be sent in random order and third parties will not know the treatment, patient or date of the reading.
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
- •Venous leg ulcer evolving for at least 3 months, the area of which is between 4 cm² and 200 cm² and the smallest axis of which is less than 10 cm and the largest axis less than 20 cm;
- •Have a Systolic Pressure Index (IPS) at the ankle between 0.89 and 1.3 and / or a systolic pressure measurement at the big toe greater than or equal to 60 mmHg;
- •Accept the port of venous compression;
- •Presenting superficial and / or deep venous insufficiency, documented on a Doppler echo dating less than one year;
- •affiliated to a social security scheme or beneficiary of such a scheme;
- •Having given their free, informed and written consent.
排除标准
- •Untreated infected wound;
- •Cancerous ulcer;
- •Treated with systemic corticosteroids or chemotherapy;
- •for which a skin graft is necessary;
- •Contraindications for the treatment of leg ulcers with the WoundEL system;
- •Pregnant or lactating women;
- •Vulnerable people or under legal/judicial protection
研究组 & 干预措施
Electrical stimulation wound management system
Two daily electrostimulation sessions using the WoundEL® device on wound two for 30 minutes at an adjustable intensity, between 5 and 42 milliampere and chosen by the patient.
干预措施: WoundEL medical device (Device)
Electrical stimulation wound management system
Two daily electrostimulation sessions using the WoundEL® device on wound two for 30 minutes at an adjustable intensity, between 5 and 42 milliampere and chosen by the patient.
干预措施: Standard cares (Other)
Standard of care
Use of dressings appropriate to the stage of healing according to French recommendations for the management of leg ulcers.
干预措施: Standard cares (Other)
结局指标
主要结局
Rate of healed-leg ulcers
时间窗: At week 8
Complete wound-healing correspond to 100% epithelialization of the leg ulcer, without persistent erosion or crusting. Complete healing of ulcers will be observed by the investigator and assessed by a third-blind.
次要结局
- Assessing the analgesic consumption(At weeks 0,2, 4, 6, 8)
- Assessing the leg ulcer healing stage(At weeks 0,2, 4, 6, 8, 10)
- Assessing the quality of life(At weeks 0,2, 4, 6, 8)
- Assessing the leg ulcer-related pain(At weeks 0,2, 4, 6, 8)
- WoundEL system security(At weeks 0,2, 4, 6, 8)