A Multi-Center, Prospective, Randomized Trial Comparing the Effectiveness of Aurix Therapy to Usual and Customary Care in Stage II-IV Pressure Ulcers
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 44
- 主要终点
- Time to Heal
研究概览
简要总结
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary Care.
详细描述
Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. Aurix is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. The results of Aurix to date when used to treat PUs have been promising. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard of care to determine time to heal at 16 weeks. Comparison will be made to patients receiving undefined Usual and Customary Care in a 1:1 manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Medicare eligible
- •≥18 years of age
- •Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage definitions)
- •The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter
- •For subjects with potentially multiple eligible PUs, the largest ulcer will be selected as the Index Ulcer for study. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
- •Debrided ulcer size between 3 cm2 and 200 cm2
- •Subject has received UCC care for ≥ 2 weeks at treating wound clinic
- •Demonstrated adequate pressure relief regimen
- •Duration ≥ 1 month at first visit
- •Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.
排除标准
- •Subjects known to be sensitive to Aurix components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
- •Stage I pressure ulcers
- •Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound
- •Presence of another wound that is concurrently treated and might interfere with treatment of index wound by Aurix
- •Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, or arterial etiology)
- •Patients on chemotherapeutic agents or any malignancy in the wound area
- •Subjects who are cognitively impaired
- •Serum albumin of less than 2.5 g/dL
- •Plasma Platelet count of less than 100 x 109/L
- •Hemoglobin of less than 10.5 g/dL
- •Subject has inadequate venous access for repeated blood draw required for Aurix Administration.
- •Life expectancy of < 6 months.
研究组 & 干预措施
Aurix + UCC
Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive Aurix treatment and usual and customary care, which can include advanced therapeutics.
干预措施: Aurix (Device)
Usual and Customary Care
Subjects will be treated on average twice a week for the first 2 weeks, and then, once a week thereafter while under active treatment, but actual frequency of treatment will be determined by the treating physician. All subjects will receive usual and customary care, which can include advanced therapeutics.
结局指标
主要结局
Time to Heal
时间窗: 16 weeks
Compare complete wound healing at 16 weeks for all pressure ulcers treated with Aurix plus standard of care with patients randomized to usual and customary care. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart (FDA Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment, 2006).
次要结局
- W-QOL (Quality of Life with Chronic Wounds) score(16 weeks)
- Proportion of healed ulcers(16 weeks)