ISRCTN21541209已完成未知
Decellularised dermis allograft for the treatment of chronic venous leg ulceration
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 71
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33811051/ (added 06/04/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 16/04/2020:
- •1. > = 18 years or older (no upper age limit)
- •2. The ability to consent to participation
- •3. 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)
- •4. A wound duration of at least 6 months
- •5. Documented venous incompetence on duplex ultrasound
- •6. Ulcer wound size > 2 cm2.
- •7. ABPI > = 0.8, or if the ABPI is incompressible, other forms of clinical assessment must exclude peripheral arterial disease (peripheral pulse examination, toe pressure, duplex ultrasound, clinical judgment)
- •*if more than one ulcer is present, the largest ulcer will be chosen as the reference ulcer for the purposes of the trial
- •Previous inclusion criteria:
- •1. > = 18 years or older (no upper age limit)
- •2. The ability to consent to participation
- •3. 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)
- •4. A wound duration of 6 to 24 months inclusive
- •5. Documented venous incompetence on duplex ultrasound
- •6. Ulcer wound size > 2 cm2.
- •7. ABPI > = 0.8, or if the ABPI is incompressible, other forms of clinical assessment must exclude peripheral arterial disease (peripheral pulse examination, toe pressure, duplex ultrasound, clinical judgment)
- •*if more than one ulcer is present, the largest ulcer will be chosen as the reference ulcer for the purposes of the trial
排除标准
- •Current exclusion criteria as of 16/04/2020:
- •1. A diagnosis of sickle cell
- •2. 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)
- •3. A clinically infected ulcer defined as evidence of erythema, cellulitis or systemically unwell
- •4. Treatment with biomedical/topical growth factors within previous 30 days
- •5. Previous history of an inability to tolerate compression therapy
- •6. Foot ulcer (i.e. below the ankle)
- •Previous exclusion criteria:
- •1. A diagnosis of sickle cell
- •2. Known sensitivities to any of the reagents/antibiotics listed on the DCD package insert
- •3. A clinically infected ulcer defined as evidence of erythema, cellulitis or systemically unwell
- •4. Treatment with biomedical/topical growth factors within previous 30 days
- •5. Previous history of an inability to tolerate compression therapy
- •6. Foot ulcer (i.e. below the ankle)
研究者
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