Evaluation of the Efficacy and Safety of a New Compression System URGO BD001 in the Treatment of Venous or Mixed Predominantly Venous Leg Ulcers
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 主要终点
- Relative reduction in wound surface area (percent)
研究概览
简要总结
The aim of this study is to evaluate the therapeutic efficacy and the safety of the new compression system URGO BD001 in the management of venous or mixed predominantly venous leg ulcers. The therapeutic efficacy will be the reduction in wound surface area during a six weeks study treatment period.
详细描述
The compression bandage URGO BD001 is indicated for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous oedema and lymphedema justifying strong compression.
The pressure applied with the compression system URGO BD001 help to improve venous return and to reduce venous oedema. The expected clinical benefits from the compression system URGO BD001 in patient with a VLU are to increase healing rate and time to healing, and to improve patient quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.8 and ≤ 1.3),
- •Wound in granulation phase (granulation tissue ≥50%),
- •Wound at least 3 cm away from any edge of another wound,
- •VLU between 2 and 20 cm2 in surface area,
- •VLU duration between 1 to 24 months.
排除标准
- •Patient under guardianship or protection of vulnerable adult,
- •Patient with known allergy to any components of the tested compression system,
- •Patient with a severe illness that might lead to premature discontinuation of the trial before the end of treatment period,
- •Patient with progressive neoplastic lesions treated by radiotherapy, chemotherapy, hormone therapy or immune suppressor,
- •Patient with non-controlled systemic infection by a suitable antibiotic therapy,
- •Patient who had a deep vein thrombosis within 3 months prior to the inclusion,
- •Patient with a lymphedema due to lymphatic obstruction,
- •Diabetic patient with advanced diagnosed microangiopathy,
- •Bedridden patient, or those spending less than one hour per day on their feet,
- •Wound covered partially or totally with necrotic tissue,
- •Clinically infected wound,
- •Wound requiring surgical treatment or for which a surgery is scheduled during the study period,
- •Cancerous lesions.
结局指标
主要结局
Relative reduction in wound surface area (percent)
时间窗: 6 weeks
Evolution between D0 and the 6 weeks treatment period with the URGO BD001 compression system: Relative reduction in wound surface area (%) = \[(SW6 - SD0)/SD0\] × 100 SD0: Wound surface area at D0 SW6: Wound surface area at Week 6
次要结局
- Safety analysis(6 weeks or last assessment)
- Venous oedema(6 weeks or last assessment)
- Patient quality of Life (EuroQoL 5D-5L)(6 weeks or last assessment)
- Complete ulcer closure:(6 weeks or last assessment)
- Evolution of the periwound skin(6 weeks or last assessment)