LeucoPatch in Malleoli Ulcer Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 9
- 主要终点
- Healing of malleoli ulcer (YES/NO)
研究概览
简要总结
An International Multicenter study evaluation, off the effect of the fully autologous growth factor-containing patch LeucoPatch, on healing of recalcitrant malleoli ulcers.
To compare the impact of LeucoPatch as part of usual care in multidisciplinary Foot clinic settings, versus usual care in the same clinics on malleoli ulcers healing.
详细描述
Diabetic Foot Ulcers are a common and severe complication, that affects Patients Life Quality. Healing time is often long and the Diabetic foot ulcer is the dominating not traumatic reason for leg amputation.
Treatment of a diabetic foot ulcer requires debridement, offloading, regularly foot care, specially tailored shoes, antimicrobial treatment, and sometimes even surgical interventions. Despite all these interventions the diabetic foot ulcer may not heal.
Malleoli ulcers in patients without diabetes share several features of pathogenesis and lack of healing potentials with the Diabetic Ulcer. Like the features of pathogenesis and lack of healing potential and are therefore included in this study.
Research has shown that other methods such as Growth factors may be a way to enhance the chance of healing.
Growth Factors have been shown to have a positive effect in studies, but no products that are characterized as autologous have as yet obtained positive results in controlled studies.
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
- None
盲法说明
Open Label
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
- •Foot ulcer at the malleoli area between 0,25 cm² and 5,0 cm²
- •Foot ulcer duration more than 6 weeks
- •No need for arterial revascularisation- as judged by the Investigator
- •informed consent
排除标准
- •Hemoglobin concentration under 6.5 mmol/l screening
- •Non-compliant with blood-letting
- •Clinically infected ulcer
- •Patient planned for or has had a revascularization procedure in the affected leg within the last 8 weeks
- •The ulcer have been treated with growth factors in the last 8 weeks
- •History of deep venous insufficiency, chronic venous leg ulcer or stasis dermatitis
- •Breast-feeding women or fertile women not agreeing to use an effective method of contraception
- •Participation in another clinical ulcer-healing study within the last 4 weeks
- •Patient has previously been randomized in this study
- •Judgement by the investigator that the patient is not able to participate in the study
结局指标
主要结局
Healing of malleoli ulcer (YES/NO)
时间窗: up to 24 weeks of treatment
Confirmed by a blinded observer
次要结局
- Z scores of combined plasma concentration of growth factors, cytokines and inflammatory markers(24 weeks)
- Health related quality of life questionnaire SF12(week 0, week 12, and week 24)
- Ulcer area reduction based on Image J measured on acetate drawing(24 weeks)
- Health related quality of life questionnaire EQ-5D(week 0, week 12, and week 24)
- Time to healing of malleoli ulcer(24 weeks)
- Pain at ulcer location(week 0, week 6, week 12 and week 24)