LeucoPatch™ Study. A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 13
- 主要终点
- Ulcer Healing Within 20 Weeks
研究概览
简要总结
The LeucoPatch™ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic foot ulcers. The study seeks to gather data for comparison with previous data from similar wounds (historical controls). By subgrouping of the treated wounds (similar to the historical controls used) an assessment of which of the patient and wound-related factors that might indicate a beneficial effect of LeucoPatch™ is sought.
详细描述
Summary: Treatment Study
The goal of the LeucoPatch ™ study is to investigate the effect of LeucoPatch ™ in diabetic foot ulcer. LeucoPatch ™ is a biologically active dressings which are made solely by the patient's own blood (autologous). It is produced in the CE (European Conformity) marked LeucoPatch™ Device and contains no additives. In this treatment study up to 75 typical diabetic patients with foot ulcers are included. These wounds are typically chronic and lead to reduced quality of life and ability to work, and extensive treatment costs. Furthermore, these wounds often lead to amputations.The study is a multicenter study in which up to 10 wound clinics are expected to be involved.
The primary endpoint is time to complete healing, the secondary endpoint is change in wound size.
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
- •Age > 18 years
- •Type I or Type II Diabetes
- •Age of wounds > 6 weeks
- •Wound area <10 cm2
- •Wounds: Texas degree ≤ type IIa
- •Perfusion status: toe pressure> 30 mmHg, or transcutaneous oxygen measurement (TcPO2)> 30 mmHg on the foot (measured within the last 3 months) or palpable foot pulse (equivalent to> 60 mmHg)
- •Diabetes control: HbA1c <12%
- •Adequate off-loading (Walker, therapy sandals etc.)
- •The patient can adhere to the treatment protocol and is expected to conclude the study
- •Written informed consent
排除标准
- •Non-Danish or Swedish speaking
- •Pregnant or nursing women
- •The patient cannot tolerate blood donation
- •Hemoglobin : < 6,5 mmol/l or 105 g/l
- •Haemophilia, Sickle cell anemia, severe thrombocytopenia, and leukemia or blood dyscrasias.
- •Patient on dialysis
- •Clinical signs of infection - including osteomyelitis (probe to bone).
- •Necrosis of the wound
- •40% change (+/-) in ulcer area in a 2-week run-in period with optimal therapy.
- •Blood vessel reconstruction within the last 4 weeks.
- •Participation in other clinical wound healing studies in the last 30 days.
- •Failure to comply with study protocol in the 2-week run-in period.
结局指标
主要结局
Ulcer Healing Within 20 Weeks
时间窗: 20 weeks
Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.
次要结局
- Ulcer Healing Within 12 Weeks.(12 weeks)