NCT00933348暂停2 期
A Randomised, Double-blind, Placebo-controlled Study of the Safety and Efficacy of the Fruit-based Product OPAL A for the Treatment of Chronic Venous and Pressure Ulcers.
Phoenix Eagle Company1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Frequency and severity of adverse events
研究概览
简要总结
The purpose of this study is to examine the safety and efficacy of the fruit-based product OPAL A for the treatment of chronic venous and pressure ulcers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female.
- •Aged ≥ 18 years.
- •Presence of either:
- •a venous leg ulcer with a surface area ≥ 2 cm2 and < 25 cm2 (best estimate of debrided wound), OR
- •a Stage II or III pressure ulcer (as per Australian Wound Management Association [AWMA] definitions)
- •Able to tolerate compression therapy (for venous ulcer group only)
- •Willing and able to provide written informed consent
- •Additional inclusion criterion after four-week standard care run-in period:
- •a less than or equal to 25% reduction in wound surface area compared with wound surface area at the screening visit
排除标准
- •Another ulcer within 10 cm of the ulcer to be treated
- •Patients with diabetes (fasting blood glucose value ≥ 7 mmol/L or random blood glucose > 11 mmol/L) that in the opinion of the investigator is uncontrolled
- •Ankle-brachial pressure index of < 0.8 (participants with venous ulcers only)
- •Alanine transaminase (ALT) or aspartate transaminase (AST) levels 3X the upper limit of normal
- •Any dermatologic condition or disorder (with the exception of dermatitis associated with venous stasis) that may interfere with the appropriate assessment and treatment of the participant's ulcer
- •Clinical signs of ulcer infection.
- •Current or recent (within the past two weeks) daily treatment with immunosuppressive medications (including oral corticosteroids; inhaled and topical corticosteroids are permitted; topical agents must not be applied within 10 cm of ulcer wound), cytotoxins or anti-inflammatory agents (intermittent non-steroidal anti-inflammatory agent use is permitted)
- •Known hypersensitivity to paw paw products
- •Pregnancy, planned pregnancy or lactation
- •Participation in another clinical trial within one month of study entry
- •Another disease or condition that in the opinion of the investigator may jeopardize the safety of the participant or their ability to participate in the study
- •Participant previously screened or randomized in this study
- •Cognitive impairment that in the opinion of the investigator leaves the participant incapable of providing informed consent
研究组 & 干预措施
OPAL A plus standard wound care
Active Comparator
干预措施: OPAL A (Drug)
Placebo plus standard wound care
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency and severity of adverse events
时间窗: Weekly from Week -4 to Week 12
Physical examination findings and vital signs
时间窗: Week -6, Day 0 and Weeks 6 and 12
Clinical laboratory assessments (full blood count [FBC], blood chemistry, liver function tests and coagulation parameters) as changed from Day 0 (i.e., baseline/randomization).
时间窗: Week -6, Day 0, Weeks 3, 6, 12
次要结局
- Time to 50% wound closure(Weekly from Weeks -6 to 12)
- Time to 100% wound closure(Weekly from Weeks -6 to 12)
- Proportion of participants with 50% or greater wound closure, or 100% wound closure at 12 weeks(Weekly from Weeks -6 to 12)
- Percentage change in wound surface area at 12 weeks(Weekly from Weeks -6 to 12)
- Participant's assessment of pain during wound dressing and wound pain in the 24 hours before each study visit (assessed using the McGill short-form pain survey)(Weekly from Week 0 to 12)
- Quality of life (QoL) scores and health state (for determination of quality-adjusted life years [QALYs]; assessed using the SF-12 health survey and the McGill short-form pain survey)(Day 0 and Weeks 6 and 12)
- Participant's and clinician/nurse overall satisfaction with treatment(Weeks 6 and 12)
- Use of health care resources/informal care(Day 0 and Weekly from Week 1 to 12)
研究者
研究点 (1)
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