A Phase I/II Clinical Trial To Determine Safety And Feasibility Of Using An Acellular Amniotic Fluid Application To Expedite Healing In Chronic Wounds
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Safety - Adverse Events Including Serious Adverse Events
研究概览
简要总结
A prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (pAF) to expedite healing in chronic wounds.
详细描述
The goal of our study is to assess, in an outpatient setting, the safety and the time to wound closure in chronic wounds treated with processed amniotic fluid (pAF). We will include patients with lower extremity full thickness wounds that are greater than 3 months old and less than 12 months old. The wound size must be greater than 5cm2 and less than 75 cm2. We will exclude anyone that requires skin grafting, or wounds with sinus tracts. Our primary objective is to determine the safety and feasibility of using pAF to treat patients with chronic wounds. The secondary objective is to determine the efficacy of pAF compared to standard of care in reducing wound area.
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
- Single (Outcomes Assessor)
盲法说明
Wound digital images will be assessed and evaluated by two University Staff members blinded to both the control and treatment group (one primary and one secondary).
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-85 years old.
- •Patients with chronic lower extremity wounds (including thermal) that are greater than 3 months, but less than 12 months old.
- •Patients with full thickness wounds.
- •Patients with at least one wound that is ≥5 cm2 and<75 cm2 in size.
- •Patient who is able to complete required site study visits and procedures in good faith
排除标准
- •Patients admitted to the hospital at the time of enrollment.
- •Patients who are pregnant, nursing or plan to become pregnant while participating in the study. If of child-bearing potential, unwillingness to use effective birth control while participating in the study.
- •Suspicion of or diagnosis of osteomyelitis underlying the wound.
- •Patients who have received an investigational agent or intervention within the prior 30 days or plan to use within the study period.
- •Patient with sinus tracts, enterocutaneous fistulas or other epithelialized tracts.
- •Patients who require skin grafting.
- •Patients diagnosed with a highly disruptive, non-controlled mental health disorder (e.g.., bipolar, or schizophrenia.
- •Patients with a history of prior drug abuse.
研究组 & 干预措施
Amniotic Fluid Injection
Processed Amniotic Fluid. Dose is 1ml/5cm2; Route: injected directly into wound; Limited to two injections. The wound will then be dressed according to standard of care.
干预措施: Processed Amniotic Fluid (Drug)
Standard of Care Wound Treatment Regimen
Primary dressings are variable and based on the moisture content and microorganism load. In general, wounds respond differently to various topical treatments. Through our clinical practice, we have found that wounds plateau with the same topical for greater than 4 weeks, hence changing antimicrobial topical helps to manage the bacterial overgrowth. We will start with our application of our slurry, a 1:1:1 ratio of Nystatin ointment, Mupirocin Ointment, and Bacitracin Ointment. This slurry will be applied directly to the cleansed wound, followed by silver gauze/foam product to all wounds. Types of silver product- site and comfort predict use of Restore, Mepilex-AG, or Mepitel-AG. If allergies to the above slurry occurs, we will use medical honey with or without bacitracin. If ointment related rash present with transition to silver product only or silver product plus medical honey.
干预措施: Standard of Care Wound Treatment Regimen (Other)
结局指标
主要结局
Safety - Adverse Events Including Serious Adverse Events
时间窗: Approximately 7 months after enrollment
Safety and tolerability will be evaluated by the PI from the results of reported signs and symptoms and scheduled physical examinations. The primary endpoint is whether the patient experienced any post-randomization, study-related serious adverse event (SAEs) while on study (collections of new AEs begins at visit two and ends at visit five which is approximately, 7 months after enrollment). An SAE is considered study-related if the medical monitor concludes the SAE is either possibly related or probably related to study participation. Although unresolved SAE's were to be monitored for 1 year or until resolution, no SAEs were unresolved at the time of study completion (approximately, 7 months after enrollment).
次要结局
- Feasibility - Reduction in Wound Size - Secondary Outcome Per Secondary Assessor(Visit 2 (approximately 6 weeks after enrollment) and Visit 5 (approximately 7 months after enrollment))
- Feasibility - Reduction in Wound Size - Secondary Outcome Per Primary Assessor(Visit 2 (approximately six weeks after enrollment) and Visit 5 (approximately 7 months after enrollment))