Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 71
- 试验地点
- 17
- 主要终点
- Proportion with a healed index ulcer at 12 weeks after randomisation.
研究概览
简要总结
Does the use of decellularised dermis allograft in addition to compression therapy promote healing in chronic venous leg ulceration compared to compression therapy alone
详细描述
Chronic venous ulceration are open wounds on the lower limbs which have been present for at least three months and are caused by a poorly functioning venous system. The affect about 1% of the general population and about 4% of those over 65. The wounds cause pain, reduced movement, and can smell - greatly affecting the quality of life of leg ulcer patients. The standard care for these patients is compression bandaging, which requires changing several times a week by community or district nurses; this drives the high cost of leg ulcer care, which can amount to £2.5 billion per annum.
Skin grafting can be used alongside compression bandaging and can help the ulcers heal faster than compression alone. Grafts can be taken from the patient's own skin, from a donor or from tissue engineered skin. An autograft (using own skin) can cause scarring and the need for a formal surgical procedure in theatre so are not suitable for all ulcer patients. Allografts (donor skin) and xenografts (animal skin) have been used successfully, but present similar drawbacks to autografts, plus the potential for the body to reject the graft and disease transmission. Tissue engineered skin has several advantages as it has been processed to remove the cells, and therefore is won't be rejected via the immune response. Human decellularised dermis (DCD) is generated from donated skin from deceased people and processed to remove the cells. It can be glued or sewn onto the skin under local anesthetic, in an out patient setting. DCD has mainly been studied in patients with diabetic foot ulceration and has shown improved healing rates and quality of life.
This study will investigate the use of DCD in addition to compression therapy versus compression therapy alone in patients with chronic venous leg ulceration.
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
盲法说明
It is not possible to mask participants or the research/clinical teams to the treatment strategy as the DCD graft is visible after application for a period of time. However the primary outcome assessments (verification of index ulcer healing visits) will be completed by an independent clinical assessor trained in the assessment of wound healing, who will have no previous involvement with, or knowledge of, the participant's index ulcer treatment and as such will be blind to the randomised treatment strategy (as the DCD is not expected to be visible after 4 weeks).
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
- •≥18 years or older (no upper age limit)
- •The ability to consent to participation
- •A diagnosis of venous leg ulceration* (defined as 'colour duplex confirmation of superficial and or deep venous reflux with any break in the skin that has either: a) been present for more than 2 weeks, or b) occurred in a person with a history of venous leg ulceration)
- •Documented venous incompetence on duplex ultrasound
- •Index ulcer wound duration of greater than 3 months
- •Index ulcer wound size ≥ 2 cm
- •ABPI ≥ 0.8
- •in light of the Covd-19 pandemic, the use of handheld continuous wave Dopplers will be allowed to diagnose venous disease to allow participants to be recruited from clinic without the need for an imaging appointment
排除标准
- •A diagnosis of sickle cell
- •Unable to receive one or more of the randomised treatment strategies for any reason at the discretion of the attending clinical team (e.g. known allergies to dCELL dermis preparation components)
- •A clinically infected ulcer defined as evidence of erythema, cellulitis or systemically unwell
- •Treatment with biomedical/topical growth factors within previous 30 days
- •Previous history of an inability to tolerate compression therapy
- •Foot ulcer (i.e. below the ankle)
结局指标
主要结局
Proportion with a healed index ulcer at 12 weeks after randomisation.
时间窗: 12 weeks
次要结局
- Disease specific quality of life using the Charing Cross Venous Ulcer Questionnaire (CCVUQ)(12 weeks, 6 months and 12 months from randomisation)
- Time to index ulcer healing from randomisation(12 months)
- The proportion of participants with a healed index ulcer at 12 months from randomisation(12 months)
- Generic quality of life using the EuroQol-5D (EQ-5D) questionnaire(12 weeks, 6 months and 12 months from randomisation)
- The cost for each patient, calculated from the healthcare resources used(12 months)
- Incremental cost-effectiveness ratio (ICER) from the EQ-5D questionnaire, with appropriate sensitivity analysis(12 months)
- The percentage change in index ulcer area in cm2 at 12 weeks from randomisation(12 weeks)
- The proportion of participants whose index ulcer healed for whom an ulcer recurred at the index site within 12 months from randomisation(12 months)