WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test A Prospective, Multi Centre, Randomised, Clinical Study on Venous Leg Ulcers
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 14
- 主要终点
- The primary end-point of this study will be to identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test
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.
Multi-centre VLU study to investigate efficacy of WOUNDCHEK™ on EPA wounds
详细描述
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.
Wounds with EPA will be determined using a new POC diagnostic test, WOUNDCHEK™ Protease Status, and the efficacy of PROMOGRAN®, a protease modulating therapy will be determined against standard of care (moist wound healing and compression) in VLU wounds in both elevated EPA and low protease activity wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 leg ulcers of venous aetiology as determined by ankle brachial pressure index (ABPI) ≥ 0.8 and able and willing to use appropriate compression therapy
- •Duration of ulcer ≥ 6 weeks ≤ 3 years
- •Ulcer is ≥ 1 cm2 ≤ 100cm2 no length longer than 10cm
- •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
- •Leg ulcers that do not have venous aetiology as determined by not been suitable for compression therapy and having an ABPI ≤ 0.8
- •Leg ulcer smaller than 1cm2 and larger than 100cm2 and has any length longer than 10cm
- •Wound duration of less than 6 weeks or longer than 3 years
- •Known hypersensitivity to any of the wound dressing used in the trial
- •Current local or systemic antibiotics in the week prior to inclusion
- •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)
- •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
结局指标
主要结局
The primary end-point of this study will be to identify EPA wounds using WOUNDCHEK™ Protease Status diagnostic test
时间窗: 12 weeks
The primary end-point of this study will be 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. An improved healing outcome for venous leg ulcers will be defined as the proportion of wounds which reach a minimum 30% percentage reduction in wound surface area over a four-week treatment period.
次要结局
- The average percentage change in protease activity levels pre and post treatment(12 weeks)