Randomized, Controlled, Open-Label, Parallel Group, Multi-Center, Prospective Phase 4 Study Comparing the Efficacy of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ULURU Inc.
- 入组人数
- 300
- 试验地点
- 28
- 主要终点
- Number of wound dressing changes
研究概览
简要总结
Pressure injuries, commonly known as pressure ulcers, affect over 2.5 million people in the United States. Pressure injuries are classified into four escalating stages, from intact skin to full thickness wounds with deep tissue loss and exposed bone. This study will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® in patients with stage 2, stage 3 and stage 4 pressure injury wounds. Altrazeal® is a Class 1, 501(k) exempt medical device listed with the FDA as a "dressing, wound, hydrogel" and has an extended wear time of up to 30 days. Subjects can be enrolled in the study either as an outpatient, or while hospitalized. Half of the subjects will be randomized to standard of care treatment, and the other half will be randomized to Altrazeal®. There are a total of up to 12 study visits taking place over 12 weeks.
详细描述
Pressure injuries, commonly known as pressure ulcers, affect over 2.5 million people in the United States. Pressure injuries are classified into four escalating stages, from intact skin with redness to full thickness wounds with deep tissue loss and exposed bone.
This study will focus on patients with stage 2, stage 3 and stage 4 pressure injury wounds. It will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® Transforming Powder Dressing (TPD). Altrazeal® is a Class 1, 501(k) exempt medical device listed with the FDA as a "dressing, wound, hydrogel" and has an extended wear time of up to 30 days. Altrazeal® is a powder dressing that conforms to the wound, covering and protecting it, shielding the wound from bacteria. Altrazeal® is used in conjunction with a secondary dressing when needed.
The primary aim of the study is to evaluate whether dressing changes can be reduced during treatment of pressure injuries. The study will also compare wound healing between the group receiving Altrazeal® and the group receiving standard of care dressings, as well as complications, pain, quality of life, and overall costs between the two groups.
Subjects will be randomized into 2 groups, standard of care and Altrazeal®. Half of the subjects will receive current standard of care treatment, and the other half will receive treatment with Altrazeal®. This is an open-label study, meaning that both the subject and the treatment provider will know what study group the subject has been randomized to.
The first visit will be the screening visit to ensure patients meet eligibility criteria. Patients can be either an outpatient or hospitalized. Written informed consent will be obtained during this visit. A wound evaluation will be performed, and laboratory work ordered, if not done recently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •18 to 85 years of age;
- •Stage 2, 3, or 4 Pressure Injuries;
- •Wound exudate is mild to moderate;
- •No clinically active wound infection (clinical diagnosis);
- •Able and willing to provide written (not proxy) informed consent;
- •Clinically stable, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment.
排除标准
- •Known allergy or hypersensitivity to TPD or its components;
- •Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;
- •Heavily exudative wounds;
- •Wound infection as defined as the presence of a least two of the following: local swelling or in duration, erythema >0.5cm around the ulcer in any direction, local tenderness or pain local warmth and purulent discharge;
- •Poorly controlled diabetes with HgbA1C >12 (as documented in the last 3 months);
- •Body Mass Index (BMI) >45 kg/m2;
- •Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb);
- •Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) <0.7 on the affected limb, if wound is located on the limb);
- •Received immunosuppression or biologics in the last six weeks and/or is expected to receive either at any point during the study;
- •Selected concurrent treatments (e.g., hyperbaric oxygen, topical oxygen therapy, electrical stimulation, ultrasound, cellular or acellular skin substitutes) during study period that may impact study outcomes;
- •Wounds with necrosis unable to undergo prior definitive debridement;
- •Active gangrene;
- •Untreated HIV;
- •Currently pregnant or lactating;
- •Impending organ transplant;
- •Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients;
- •Unwilling or unable to comply with offloading recommendations;
- •If, in the opinion of the clinical investigator, a subject is a poor candidate for this study because:
- •Unable to keep research appointments;
- •Poorly controlled incontinence which may impact study outcomes (e.g., depending on the location of the wound);
- •Participated in another investigative study within 3 months of enrollment that could interfere with study outcomes;
- •Active alcohol or substance abuse (cocaine, heroin, or other substances) that may interfere with healing or subject compliance with visit schedules;
- •Concurrent clinical condition(s) that could pose a health risk to patient or influence outcome of study;
- •Not suitable for study participation. -
结局指标
主要结局
Number of wound dressing changes
时间窗: 12 weeks
The number of primary dressing changes for each treatment group will be compared.
次要结局
- Complications (problems) from treating the pressure wound(12 weeks)
- Wound Quality of Life(12 weeks)
- Wound healing(12 weeks)
- Pain in the wound and from dressing changes.(12 weeks)