GrafixPL PRIME Evaluation Case Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Participants With Complete Closure of the Index Ulcer
研究概览
简要总结
The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40) that receive optimal treatment including serial wound debridement and off-loading with total contact casts or a boot and GrafixPL PRIME. In addition, the investigators will collect data on other potential confounding factors that could affect healing such as medications, tobacco, nutrition, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated. The objective of this study is to understand the use of this product to evaluate wound healing in 40 patients.
详细描述
Screening and Enrollment:
- Review and sign the Informed Consent and HIPAA Authorization
- Review the inclusion and exclusion criteria
If the subject qualifies for the study, they will participate in the following procedures (weekly visits, +/-4 days):
Visit 0:
- Demographics (such as age, gender, race or ethnicity)
- Medical/Surgical and Social History, Current Antibiotics.
- Laboratory Results
- Vascular - ABI
- Neurological evaluation - Monofilament and VPT
- Vitals - Sitting blood pressure and Pulse rate, Height/Weight, and BMI
- Wound debridement
- eKare - Wound imaging measurement
- Application of GrafixPL PRIME
- Current Antibiotics
- Offloading
- Adverse Events
- Source documentation
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •18-90 years of age
- •Chronic foot ulceration below the ankle - persistent for 30 days or longer
- •Ankle Brachial Index (ABI) >0.5 (Bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to surgery)
排除标准
- •Unable to provide informed consent
- •<18 or >90 years of age
- •History of poor compliance with follow-up visits
- •Untreated Osteomyelitis
- •Widespread malignancy
- •Active alcohol or substance abuse such as cocaine, heroin, or methamphetamines
- •Currently Pregnant or planning pregnancy during the course of intended participation in the study
- •Is nursing or actively lactating
结局指标
主要结局
Number of Participants With Complete Closure of the Index Ulcer
时间窗: 12 weeks
Complete closure of the index ulcer, defined as 100% re-epithelialization as determined by the Investigator by week 12 or the End of Treatment Visit.
次要结局
- Time to Closure(12 weeks)
- Total Adverse Events(12 weeks)
研究者
Larry Lavery
Professor and Director of Research
University of Texas Southwestern Medical Center