LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Healing rate of Problematic wound area
研究概览
简要总结
The trial compare the healing rate of chronic wounds with exposed tendon or bone ('problematic wound area') with LeucoPatch® treatment for 8 up to 16 weeks in addition to usual care versus usual care.
The healing rate will be measured as relative reduction of 'problematic wound area' at 8 weeks
详细描述
A certain subpopulation of plastic surgery patients has chronic, non-healing wounds with exposed bone or tendon e.g. located on the scalp or extremities. The chronic non-healing wounds are characterized by no significant wound area reduction within 4 weeks of standard wound treatment. Standard wound treatment includes mechanical or sharp serial debridement and low pressure irrigation for cleansing and wound dressings ensuring moist wound healing. Exposed bone or tendon in a chronic wound can be described as a potentially 'problematic wound area', since the healing by sound granulation tissue from the soft tissue sides of the wound to cover the problematic wound area is often reduced or absent.
The subpopulation is characterized by either referral from other specialties with non-healing wounds of various etiologies and no or limited options of medical, surgical, or reconstructive plastic surgery procedures to treat the wounds; or the wounds are a consequence of previous reconstructive procedures with unsuccessful outcome and no or limited options of further reconstructive surgery. This group of patients often needs wound treatment for a very long period (months-years) to heal, in spite of best practice standards of wound treatment. Treatment with xenogeneic acellular dermal matrixes and autologous full- or split-thickness skin grafts may be an option, but it often requires general anesthesia and a 2-staged approach. The LeucoPatch may be a new solution in wound treatment, which can be used in the outpatient clinic, to promote faster healing in patients with chronic, non-healing wounds with exposed bone or tendon
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
A blinded assessor will evaluate wound healing at the first woundhealing and 2 weeks after woundhealing
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
- •Written informed consent obtained before any trial related procedures are performed
- •Aged ≥18 years
- •A documented clinically relevant history of chronic wound with exposed tendon and/or bone. Chronic is defined as a non-healing wound over the past 4 weeks with standard care in a specialized clinic.
- •'Problematic wound area' between 0.25 and 10.0 cm2 measured by Image J at S1- irrespective of the total wound size
- •The subject must be willing and able to comply with the trial protocol
排除标准
- •Haemoglobin < 6.0 mmol/l available at screening (see 10.10)
- •Non-compliance with blood-letting
- •Clinically infected wound or suspected osteomyelitis in the wound area
- •For lower extremity wounds: Critical peripheral artery disease (absence of foot pulse and Ankle-Branchial Pressure Index, ABPI <0.9 and ankle blood pressure < 50 mmHg)
- •For lower extremity wounds: History of vascular by-pass graft or other endovascular intervention within 3 months prior to inclusion.
- •Malignancy in the wound area
- •Need for dialysis
- •Hemophilia, leukaemia or other significant blood disease
- •History of alcohol or drug abuse within the last year
- •Weight abnormality (BMI < 20 kg/m2 or >30 kg/m2)
- •Pregnant or lactating woman
- •Women of childbearing potential who are not using sufficient contraceptives
- •Patient has previously been randomised in this study
- •Participation in another investigational drug trial within the last 10 weeks
结局指标
主要结局
Healing rate of Problematic wound area
时间窗: 8 weeks
Measured as relative reduction of Problematic wound area
次要结局
- Local pain(8 to 16 weeks)
- Complete 'problematic wound area´coverage(8 weeks or until 16 weeks)
- Safety(16 weeks)
- Complete healing of target wound(8 or until 16 weeks)
- Time to complete healing or coverage with granulation tissue(until 16 weeks)
- Long -term followup(36 weeks)
研究者
Jais Oliver Berg
Senior Consultant,
Nordsjaellands Hospital