A Multi-centre, Pilot, Prospective Trial of DermaRep™ Device in the Treatment of Venous Leg Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biovotec AS
- 入组人数
- 39
- 试验地点
- 12
- 主要终点
- Assessment of adverse events following DermaRep™ treatment
研究概览
简要总结
This is a First in Human clinical study on the safety and effectiveness of DermaRep™ wound contact dressing. Patients with venous leg ulcers will be treated with standard of care dressings and compression for 4 weeks to establish a baseline wound healing response. All patients will then be treated with DermaRep™ wound contact dressing in addition to standard of care for a further 8 weeks. If the wound has not healed, patients will continue treatment with standard of care only for a further 4 weeks. All patients will be assessed at the 16 week timepoint, the primary endpoint.
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
- •The patient is at least 18 years of age
- •The patient is male and female not pregnant or lactating and using contraception
- •The patient has a confirmed venous leg ulcer with:Confirmed actively managed reflux; No exposed tendon or bone; Ulcer surface area between 2cm2 and 80cm; ABPI>0.8
- •The patient agrees to abstain from enrolment in any other clinical trial for the duration of the study
- •The patient is able to understand the aims and objectives of the trial and is willing to consent
排除标准
- •Study treatment area has exposed bone or tendon
- •Poorly controlled diabetes
- •Arterial insufficiency (ABPI<0.8)
- •Pregnant/lactating females (tested as per institutional requirements)
- •The patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma granulosum)
- •The patient is unable to follow the procedures set by the protocol
- •The patient has a history of any significant cardiac, pulmonary, renal. hepatic, neurological and/or immune dysfunction that in the opinion of the investigator may compromise patient safety or study objectives
- •The patient is taking any known medications that in the opinion of the investigator may compromise patient safety or the study objectives
- •The patient has any known allergies to any of the device materials to be used in the trial (egg allergy)
- •The patient is a vulnerable or protected adult
- •The patient is unable to provide consent
结局指标
主要结局
Assessment of adverse events following DermaRep™ treatment
时间窗: 12 weeks
Potential adverse events following DermaRep™ treatment will be compared to the pre-treatment phase, the 4 week run-in period. Adverse events will include active bleeding, clinical infection and device deficiencies.
次要结局
- Condition of the surrounding skin(12 weeks)
- Evaluation of the performance of DermaRep™ in rate of wound healing.(12 weeks)
- Exudate levels(12 weeks)
- Assessment of Wound Pain(12 weeks)
- DermaRep™ Dressing Application(12 weeks)
- Comparison of healing between the run-in period and the treatment period(12 weeks)
- Reduction in wound area/volume(12 weeks)
- Wound coverage(12 weeks)
- Wounds healed at 12 weeks(12 weeks)
- Time to healing(12 weeks)