NCT01743053已完成4 期
A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 13
- 主要终点
- Wound healing
研究概览
简要总结
This is a prospective, randomised, open label, controlled pilot study to evaluate the safety and preliminary effectiveness of the ReCell Autologous Cell Harvesting Device (ReCell) for the management of chronic leg ulcers associated with venous insufficiency. Outcome will be compared between study participants receiving standard care (debridement, compression therapy) and participants receiving ReCell in addition to standard 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
- 否
入选标准
- •Chronic venous leg ulcer (CEAP Clinical classification of 6)
- •Confirmed, actively managed venous reflux
- •No exposed tendon or bone
- •Ulcer is >4 weeks in duration
- •Ulcer surface area between 2cm2 and 80cm2
- •The patient is 18 years of age or older
- •The patient is willing to complete all follow-up evaluations required by the study protocol
- •The patient is able to abstain from any other treatment of the ulcer for the duration of the study, unless medically necessary
- •The patient agrees to abstain from enrolment in any other clinical trial for the duration of the study
- •The patient is able to read and understand instructions and give voluntary written informed consent
- •The patient is able and willing to follow the protocol requirements (including compression therapy)
- •Patients enrolling at any site in France must have an affiliation to a social security scheme
排除标准
- •Study treatment area has exposed bone or tendon
- •Poorly controlled diabetes
- •Arterial insufficiency (ABI < 0.8)
- •Pregnant/lactating females (self-reported or tested, per institutional requirements)
- •The patient has an active wound infection requiring antibiotic therapy
- •The patient has had a prior surgical treatment of the ulcer within the past 60 days
- •The patient has a life expectancy of 1-year or less
- •The patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum).
- •The patient is unable to follow the protocol
- •The patient is taking, or has taken in the past 60 days, mycophenolate mofetil or >10mg of corticosteroids per day.
- •The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
- •The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.
- •The patient is a vulnerable or protected adult.
- •The patient is unable to provide consent
结局指标
主要结局
Wound healing
时间窗: 12 weeks
The primary objective of the study is to assess the difference in incidence of ulcer closure (investigator assessed as complete epithelialisation without drainage) between the ReCell group and the control group.
次要结局
- Wounds characterization/Quality of Life(At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks))
- Dressing Change(At each follow-up visit (1, 2, 4, 6, 8, 12, 24, 52 weeks) until healed)
研究者
研究点 (13)
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