WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 9
- 主要终点
- To identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test, and to compare the healing outcomes of two treatment regimes (PROMOGRAN®, a protease modulating therapy and current standard of care) on chronic wounds with EPA.
研究概览
简要总结
The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes.
It is hypothesized that protease modulating dressings may provide significantly better clinical outcomes on EPA wounds over current standard of care.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged ≥ 18 years old
- •Patients with a diabetic foot ulcer as defined by Wagner grade 1 - 2
- •ABPI of ≥0.6 to ensure ischemia will not impact healing
- •No restriction on wound size or wound location
- •Duration of ulcer ≥ 6 weeks ≤ 2 years
- •The patient must be able to understand the trial and provide written informed consent
- •No local or systemic signs of infection, with normal CRP and leukocyte levels below 10 000
- •Wound has not been treated with PROMOGRAN® in 4 weeks prior to inclusion
排除标准
- •Wound duration of less than 6 weeks or longer than 2 years
- •Known hypersensitivity to any of the wound dressing used in the trial
- •Current local or systemic antibiotics in the week prior to inclusion
- •Patients with significant ischemia as defined by ABPI of ≤0.6
- •Clinical infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema.
- •Progressive neoplastic lesion treated by radiotherapy or chemotherapy
- •Prolonged treatment with immunosuppressive agents or high dose corticosteroids
- •Patients who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse)
- •Patients with renal insufficiency (with eGFR values <30 or on RRT) Life expectancy of <6 months
- •Patients with uncontrolled diabetes as determined by Hb-A1c ≥ 12% ( = Hb-1CIFCC ≥ 107.65 mmol/mol)
- •Patients who have participated in a clinical trial on wound healing within the past month
- •Patients who are unable to understand the aims and objectives of the trial
- •Patients with a known history of non adherence with medical treatment
- •Females who are pregnant
- •Subject has Acquired Immunodeficiency Syndrome (AIDS) or is known to be infected with Human Immunodeficiency Virus (HIV)
- •Subject has viral hepatitis
研究组 & 干预措施
Low EPA and standard of care
Low EPA wounds will be treated with the standard of care for diabetic foot ulcers.
干预措施: Tielle (Device)
Promogran and High EPA
Wound with high EPA will be treated with promogran and covered with a secondary dressing that is standard of care
干预措施: PROMOGRAN (Device)
Promogran and Low EPA
Wounds with low EPA will be treated with Promogran and covered with a secondary which is standard of care
干预措施: PROMOGRAN (Device)
High EPA and standrad of care
Wounds with high EPA will get standard of care as in line with current practice as they is no other test currently available for EPA
干预措施: Tielle (Device)
结局指标
主要结局
To identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test, and to compare the healing outcomes of two treatment regimes (PROMOGRAN®, a protease modulating therapy and current standard of care) on chronic wounds with EPA.
时间窗: 4 weeks
An improved healing outcome for diabetic foot ulcers ulcers will be defined as the proportion of wounds which reach a minimum 50% percentage reduction in wound surface area over a four-week treatment period.
次要结局
- Reduction in wound area and cost effectiveness(12 weeks)