NCT00627094已完成不适用
A Randomised, Controlled and Double-blind Clinical Investigation on the Effectiveness and Safety of a Foam Dressing Biatain Ibu Non-adhesive vs. Biatain Non-adhesive, in Painful Chronic Venous Leg Ulcers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 26
- 主要终点
- Pain Relief
研究概览
简要总结
The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.
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
- Triple (Participant, Care Provider, Investigator)
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
- •>= 18 years of age
- •Chronic venous leg ulcer on the lower leg
- •Ulcer duration >= 8 weeks
- •Pain intensity in study ulcer at least 4 on an 11-point numerical box scale (NBS): 0= no pain, 10= worst possible pain
- •Exudate level moderate to high
- •Ulcer size min 1.6 cm and max 11 cm in any direction
- •Ankle/brachial index >= 0.8
- •Treated with moist wound healing during the past 2 weeks prior to inclusion
- •Adequate compression therapy during the past 2 weeks prior to inclusion
- •The patient is cognitive capable of evaluating his/her pain relief and pain intensity
- •The patient is able to understand the treatment and is willing to comply with the treatment regimen.
- •The patient is able to complete the patient diary
- •The patient is willing and able to give written informed consent
排除标准
- •Painful ulcers that have been treatment resistant to analgesics for the past 6 months or more
- •Pregnant or lactating women
- •Known and verified hypersensitivity to any content of the products used in this investigation
- •Local infection (bacterial imbalanced wound) in the study ulcer
- •Clinical infection in the study ulcer
- •Diseases: Vasculitis, erysipelas and cellulitis of the peri-ulcer skin
- •The investigator considers the patient not eligible
- •Diseases and conditions where ibuprofen or other analgesics are contraindicated (including known hypersensitivity to Aspirin (acetylsalicylic acid) or other analgesics, especially associated with a history of asthma, rhinitis or urticaria)
- •Use of per need medication for the past 3 days
- •Concomitant treatment with systemic antibiotics other than nitrofurantoin
- •Concomitant treatment with systemic corticosteroids (more than 10 mg/day prednisolon or equivalent) or other immunosuppressants within 1 month prior to inclusion
- •Concomitant treatment with cancer chemotherapeutics
- •Concomitant participation in other studies
- •Previous participation in this study
研究组 & 干预措施
Biatain Ibu
Experimental
Biatain Ibu
干预措施: Biatain Ibu (Device)
Biatain
Active Comparator
Biatain
干预措施: Biatain (Device)
结局指标
主要结局
Pain Relief
时间窗: Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)
The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.
次要结局
- Pain Intensity (PI) Change(Change from baseline in Pain Intensity (PI) on day 4 evening)
- Change From Baseline in Ulcer Area(Change from baseline to end of trial (day 43))
- Adverse Events(Continuously from start of treatment to end of trial (day 43))
研究者
研究点 (26)
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