A Multicenter, Prospective, Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care Versus Matched Controls in the Management of Nonhealing Pressure Ulcers
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Complete Closure
研究概览
简要总结
A multicenter, prospective, clinical trial evaluating a single-layer amniotic membrane (XPURT) and standard of care versus matched controls in the management of nonhealing pressure ulcers.
详细描述
This study is a multi-center, prospective, controlled clinical study consisting of 100 subjects from up to 30 providers. The subjects receive XPURT and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of XPURT + SOC for up to 20 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional for both arms, for the purpose of changing only (1) the secondary dressing in the XPURT arm or (2) change the standard of care dressing in the control arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •The potential subject must be at least 18 years of age or older.
- •The potential subject must agree to attend the weekly study visits required by the protocol.
- •The potential subject must be willing and able to participate in the informed consent process.
- •The potential subject must have a full thickness pressure ulcer NPIAP stage 3 through stage 4 without exposed bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial).
- •At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100 cm2 measured post debridement with the imaging device.
- •The potential subject has adequate off-loading of the ulcer.
排除标准
- •The potential subject is known to have a life expectancy of < 3 months.
- •The potential subject's target ulcer is not a pressure ulcer.
- •The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
- •The target ulcer exposes tendon or bone.
- •There is undermining at the wound edge or tunnelling.
- •There is evidence of osteomyelitis complicating the target ulcer.
- •The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
- •The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
- •The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit(For diabetics only).
- •The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
- •The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.
- •The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months.
- •The potential subject has end stage renal disease requiring dialysis.
- •The potential subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
- •The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- •The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
- •The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutritional Assessment.
- •The potential subject has a known or suspected sensitivity to glutaraldehyde solutions.
研究组 & 干预措施
Standard of Care
Debridement, off-loading, reduction of bacterial burden, and proper moisture balance using dressings.
干预措施: Standard of Care (Other)
XPURT + SOC
Single-layer amniotic membrane plus standard of care.
干预措施: XPURT + SOC (Other)
结局指标
主要结局
Complete Closure
时间窗: 1-22 Weeks
The percentage of target ulcers achieving complete wound closure in 20 weeks.
次要结局
- Time to Healing(1-22 Weeks)
- Percentage of Wound Area Reduction(1-22 Weeks)
- Adverse Events(1-22 Weeks)
- Measure Pain(1-22 Weeks)
- Average Product Usage(1-22 Weeks)
- Measure Quality of Life(1-22 Weeks)