A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri- Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 7
- 主要终点
- Wound Closure
研究概览
简要总结
CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs
详细描述
A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs
Hybrid prospective platform 2 arm, comparative, randomized multicenter study with a CSM matched retrospective control group Interventional comparative study
- IP 1: BioLab Membrane Wrap Lite
- IP2: BioLab Tri-Membrane Wrap
Standard of care: Debridement, maintenance of proper moisture balance, reduction in bacterial burden, offloading and multilayer compression.
Patients with nonhealing venous leg ulcerations or diabetic foot ulcers of at least 4-weeks duration that have failed to show 50% PAR with SOC therapies Patients receiving SOC therapies for hard-to-heal VLUs and/or DFUs
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
- •Male or female 18 years of age and older
- •2. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of >4 weeks duration and visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks
- •Subjects' wound size is minimum of 2 cm2 and maximum of 25cm2
- •If the subject has more than one eligible wound the largest wound will be selected (the index wound)
- •Subject is able and willing to follow the protocol requirements
- •Subject has signed informed consent
排除标准
- •Inability to adhere to the study protocol or study visit schedule
- •Child-bearing potential without appropriate contraception
- •Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.
- •Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)
- •The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
- •Known contraindications to the use of amniotic tissue grafts
- •The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics
研究组 & 干预措施
Standard of Care
This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group.
Subjects will be randomized to one of two interventions:
IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap
Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 165 in wound type.)
IP1: BioLab Membrane Wrap Lite
This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group.
Subjects will be randomized to one of two interventions:
IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap
Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 165 in wound type.)
干预措施: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap (Other)
IP2: BioLab Tri-Membrane Wrap
This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group.
Subjects will be randomized to one of two interventions:
IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap
Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 165 in wound type.)
干预措施: IP2: BioLab Tri-Membrane Wrap (Other)
结局指标
主要结局
Wound Closure
时间窗: 12 Weeks
To demonstrate the clinical effectiveness of IP1 and IP2 as an adjunct to standard of care in supporting wound healing compared to standard of care alone in venous leg ulcers and diabetic foot ulcers across the continuum of care. Thus, the incidence of index ulcers obtaining complete wound closure by 12 weeks will be collected.
次要结局
- Wound percent area reduction(Weeks 4, 8, and 12)