A Prospective, Randomized, Controlled Study of the Efficacy of Sharp Debridement for the Management of Chronic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The primary objective of this study is to evaluate subjects enrolled and randomized to the weekly sharp debridement group.
研究概览
简要总结
Standard care of care and up to twelve (12) weekly debridements. Subjects randomized into the weekly debridement group will receive up to twelve (12) debridement during the twelve (12) weeks of the study. There will be two (2) subject groups in the study. Subjects will be randomized into either the monthly debridement group or the weekly debridement group.
详细描述
The primary objective of this study is to evaluate subjects enrolled and randomized to the weekly sharp debridement group.
The major secondary objectives are incidence of complete wound closure at Week 12, rate of healing, ulcer recurrence, wound characteristics, and microbiologic information.
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
- •Subject must have evidence of a full-thickness cutaneous wound of at least 30 days duration.
- •Subject must be at least 18 years of age.
- •Subject must have a minimum life expectancy of at least 1 year to be determined by the Investigator.
- •The study ulcer must be from 1 cm2 to 20 cm2 in size.
- •The study ulcer must have been present for at least 30 days at study Day -
- •The subject's Glycosylated hemoglobin (HbA1C) must be equal to or less than 10.0% for subjects with diagnosed diabetes at study Day
- •The subject, legal guardian or authorized representative must have understood, signed and dated the IRB approved informed consent form.
- •The subject must be available for evaluation on a weekly basis for the twelve (12) weeks of the study. Visits at Week 13 and Week 14 are required for initial wound healing, which is achieved in study Week 11 or
- •The Investigator will evaluate both groups at Week
- •Subjects must be available for evaluation at Week
- •The subject's TCpO2 must be equal to or greater than 25 mm of mercury in the periwound area and ABI greater than 0.7.
排除标准
- •Subject whose ulcer has healed 30% or greater from the evaluation Study day -7 to the post-debridement Study Day 0 as determined by wound measurements using ARANZ Silhouette
- •A history of alcohol or substance abuse, within the previous year, which could, or in the judgment of the Investigator, would interfere with study compliance or protocol requirements.
- •Participation in clinical trials evaluating investigational pharmaceuticals, biologics or devices within 30 days of admission to the study.
- •Subject with a history of receiving any of the following within the last 30 days: systemic corticosteroids exceeding a total daily dose of 20mg, immunosuppressive agents, radiation therapy or chemotherapy. Anticipated use of the above during the study period will also exclude a subject from entry into the study. Topical and inhaled corticosteroids are not prohibited.
- •Subjects with medical comorbidities known to affect wound healing such as end stage renal disease, severe hepatic insufficiency, vasculitis, and HIV will be excluded from this study
研究组 & 干预措施
debridement
monthly vs weekly debridement
干预措施: debridement (Procedure)
结局指标
主要结局
The primary objective of this study is to evaluate subjects enrolled and randomized to the weekly sharp debridement group.
时间窗: 12 weeks
次要结局
- The major secondary objectives are incidence of complete wound closure at Week 12, rate of healing, ulcer recurrence, wound characteristics, and microbiologic information.(12 weeks)
研究者
Randall Wolcott
Prinicipal Investigator
Southwest Regional Wound Care Center