A Pilot Randomized Controlled Trial to Evaluate an Advanced Borderless Dressing (ALLEVYN LIFE Non-Bordered) in the Treatment of Chronic Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 12
- 主要终点
- Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit
研究概览
简要总结
This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.
详细描述
The study is a pilot RCT, which will generate the first comparative clinical, economic, and safety data for use of ALNB in subjects. A small sample of subjects with a range of chronic, moderate to highly exuding ulcer types (LU [arterial/mixed etiology leg ulcers or venous leg ulcers requiring compression therapy], PU, and non-ischemic DFU) will be enrolled and followed for 12 weeks to study the impact on health-related quality of life, ulcer progression and healthcare resource utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit
时间窗: Baseline through 6 weeks
The primary objective was to estimate the effect of treatment with ALLEVYN Life Non-Bordered (ALNB) on Health-Related Quality of Life (HRQoL) in subjects with chronic ulcers, measured using the CWIS-PSDL scale, compared to subjects receiving standard care (SC) alone over a 6-week treatment period. The CWIS is a questionnaire to measure the impact of chronic wounds on patient health-related quality of life and identify areas of patient concern. The CWIS-PSDL score is transformed on to a 0-100 scale, where a high score indicates a positive rating. The following calculation is used: CWIS-PSDL = (Sum of PSDL item scores-N_PSDL)/(N_PSDL "x" 4) ×100, where NPSDL = count of 24 questions completed (experience and stress) PSDL Sub-scores are based on 24 questions (12 items on the extent of the problem and 12 on the associated stress), each graded on a 5-point Likert scale \[1-5\]) with higher scores indicating a better outcome.
次要结局
- Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(Baseline, Weeks 3, 6, and 12)
- Ulcer Progression Assessed by Change From Baseline in Wound Depth(Baseline, Weeks 3, 6, and 12)
- Healthcare Resource Use - Number and Type of Compression Dressings Used(Baseline through 12 weeks)
- Healthcare Resource Use - Number of Participants Requiring Hospital Admission(Baseline through 12 weeks)
- Healthcare Resource Use - Number of Days Participants Required In-Hospital Care(Baseline through 12 weeks)
- Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(Baseline, Weeks 3, 6, and 12)
- Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(Baseline, Weeks 3, 6, and 12)
- Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks(PSDL: baseline, 3 and 12 weeks; WB, SL, GQ, and SQ: baseline, 3, 6, and 12 weeks)
- Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(Baseline, Weeks 3, 6, and 12)
- Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(Baseline, Weeks 3, 6, and 12)
- Ulcer Progression Assessed by Change From Baseline in Wound Volume(Baseline, Weeks 3, 6, and 12)
- Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used(Baseline through 12 weeks)
- Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score(Baseline, Weeks 3, 6, and 12)
- Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(Baseline, Weeks 3, 6, and 12)
- Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(Baseline, Weeks 3, 6, and 12)
- Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition(Baseline, Weeks 3, 6, and 12)
- Ulcer Progression Assessed by Change From Baseline in Wound Area(Baseline, Weeks 3, 6 and 12)
- Number of Participants With Reference Wound Healed(Weeks 3, 6 and 12)
- Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change(Baseline through 12 weeks)
- Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(Baseline, Weeks 3, 6, and 12)
- Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement(Baseline through 12 weeks)