A Multi-Center, Prospective, Cohort Trial Comparing the Effectiveness of AutoloGel Therapy to Usual and Customary Care in Stage II-IV Pressure Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cytomedix
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Time to complete wound healing
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, case-matched cohort-controlled trial in which pressure ulcers will be treated using AutoloGel and standard care and case-matched against a concurrent cohort of 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. AutoloGel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. The results of AutoloGel 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, case-matched cohort trial in which pressure ulcers will be treated using AutoloGel and standard of care to determine time to heal at 16 weeks. Comparison will be made with a case matched concurrent cohort of patients receiving undefined Usual and Customary Care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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/Medicaid 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.
- •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
- •Demonstrated adequate offloading 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 AutoloGel 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 AutoloGel
- •Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, or arterial etiology)
- •Any malignancy other than non-melanoma skin cancer
- •Subjects who are cognitively impaired and do not have a healthcare proxy
- •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 AutoloGel Administration.
- •Life expectancy of < 6 months.
结局指标
主要结局
Time to complete wound healing
时间窗: 16 weeks
Compare complete wound healing at 16 weeks for all pressure ulcers treated with AutoloGel plus standard of care with case-matched concurrent controls. 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
- Ulcer recurrence(1 year)
- Number of patients with adverse events as a measure of tolerability(16 weeks)
- Proportion of healed ulcers(16 weeks)
- W-QOL (Quality of Life with Chronic Wounds) score(16 weeks)