NCT02716519撤回4 期
Clinical Outcomes for Chronic Ulcers Treated With Clostridial Collagenase (SANTYL®) Versus Standard Care Within the Continuum of Care of an Accountable Care Organization (ACO)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Target Ulcer Complications
研究概览
简要总结
This study is designed to assess the comparative effectiveness of SANTYL® versus standard of care in the treatment of pressure ulcers and diabetic foot ulcers within the continuum of care of an ACO. After meeting study criteria, participants will be randomly assigned to apply Santyl or standard care to their pressure ulcer or diabetic foot ulcer for up to 6 weeks. Participants will be followed for one year from the date of randomization to assess ulcer status and ulcer complications.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Target Ulcer Complications
时间窗: 12 months
Target ulcer complications from baseline to the end of the assessment period in each treatment group: * increase in size by more than 25%, * cellulitis, * ulcer infections, * osteomyelitis, * requirement for surgical intervention
次要结局
- The incidence of cellulitis between treatment groups during the assessment period(12 months)
- During the post-acute phase, weekly patient and caregiver time for target ulcer treatment(6 months)
- Emergency department visits for target ulcer treatment(12 months)
- During the acute phase, daily time at bedside for target ulcer treatment(6 months)
- The incidence of ulcer infections between treatment groups during the assessment period(12 months)
- Hospital readmission for target ulcer treatment(12 months)
- During the post-acute phase, weekly clinician time at bedside for target ulcer treatment(12 months)
- The incidence of increase in ulcer size by more than 25% between treatment groups during the assessment period(12 months)
- Percentage change in ulcer area from baseline to the end of treatment period(12 months)
- During the acute phase, daily lab tests for target ulcer treatment(6 months)
- The incidence of osteomyelitis between treatment groups during the assessment period(12 months)
- The incidence of requirement for surgical intervention between treatment groups during the assessment period(12 months)
- Study discontinuations (target ulcer related)(12 months)
- During the acute phase, daily wound care products (including dressings) for target ulcer treatment(6 months)
- During the post-acute phase, weekly wound care products (including dressings) for target ulcer treatment(6 months)
- During the post-acute phase, weekly antibiotics and analgesics used for target ulcer treatment(6 months)
- During the acute phase, daily antibiotics and analgesics used for target ulcer treatment(6 months)
- During the acute phase, daily surgical procedures for target ulcer treatment(6 months)
- During the post-acute phase, weekly surgical procedures for target ulcer treatment(6 months)
- During the post-acute phase, weekly lab tests for target ulcer treatment(6 months)
研究者
研究点 (2)
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