A Prospective, Multicenter, Randomized, Controlled Clinical Study Of PuraPly® AM and Standard of Care (SOC) Compared to SOC Alone For The Management Of Stage II-IV Pressure Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Improvement in wound bed condition between groups
研究概览
简要总结
This is a prospective, multi-center, randomized, controlled clinical study Of PuraPly® AM and standard of care (SOC) compared to SOC alone for the management of Stage II-IV pressure ulcers located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.
详细描述
This study seeks to demonstrate how PuraPly® AM performs against standard of care in Stage II-IV Pressure Ulcers through a prospective randomized controlled study design.
Subjects may be enrolled for up to 24 weeks; if healing occurs prior to week 24, a follow up healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure and participation may continue up to 24 weeks. Subjects that are randomized to the SOC group have the opportunity to cross over and receive PuraPly AM at week 12 if their index ulcer has not healed; they will then be followed for an additional 12 weeks for up to 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 18 years of age.
- •Subject has a Stage II-IV pressure ulcer located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.
- •Pressure ulcer should be present for 4 weeks duration and have a ulcer surface area > 2cm2
- •If multiple ulcers are present, one ulcer must be identified as the index ulcer.
- •The index ulcer is free from active infection at the time of randomization.
- •Willingness to off-load or pressure redistribute ulcer for duration of enrollment
- •The index ulcer has been offloaded for at least 7 days prior to randomization.
- •The index ulcer must have been present for at least 30 days at time of study enrollment.
- •The index ulcer is separated at least 4 cm from all other ulcers at Study Day -7 and Study Day 0 (post-debridement) and has a margin of intact skin sufficient for anchoring of the required study dressing.
- •Subject has read and signed the IRB/IEC approved Informed Consent Form (ICF) before screening procedures are undertaken.
排除标准
- •Presence of signs and symptoms of infection at the index ulcer site, including but not limited to cellulitis, acute osteomyelitis, excessive exudate, gangrene or deep tissue infection
- •The index ulcer is not free of necrotic tissue and is unable to tolerate debridement
- •Non-enteric or unexplored sinus tract
- •Concomitant conditions that in the judgment of the investigator would make the subject inappropriate for entry to the study
- •Subject has a known sensitivity to porcine materials
- •Subject has a known sensitivity to polyhexamethylenebiguanide (PHMB)
结局指标
主要结局
Improvement in wound bed condition between groups
时间窗: Up to 24 weeks
As measured from change in status from baseline
Reduction in size of ulcer area between groups
时间窗: Up to 24 weeks
As measured from change in size from baseline
次要结局
- Improvement in patient reported pain(Up to 24 weeks)
- Improvement in patient reported quality of life(Up to 24 weeks)
- Time to complete wound closure between both groups(Up to 24 weeks)