NCT05312762招募中不适用
An Open Label, Multicentre, Randomized Phase IV Clinical Trial to Evaluate the Safety and Efficacy of MaxioCel Compared With Aquacel Extra for the Management of Exuding Chronic Wounds
Axio Biosolutions Pvt. Ltd.7 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2022年4月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 7
- 主要终点
- Wound Area Measurement
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of MaxioCel vs Aquacel Extra in the management of exuding ulcers/wounds over a period of 4 weeks
详细描述
The current study intends to compare the efficacy of the chitosan wound dressing (MaxioCel) with another marketed dressing (Aquacel Extra). MaxioCel is made up of chitosan and Aquacel Extra with carboxymethyl cellulose. Both are polymeric dressings.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 years old or above (till 80 years)
- •Patients who are willing to sign the written informed consent
- •Clinically diagnosed with an unhealed or non-healing diabetic foot ulcer / venous ulcer / arterial ulcer / other ulcers / wounds, etc.
- •Wound duration between 1 to 24 months
- •A target wound area between 1 cm2 and 50 cm2
- •Exuding wounds / ulcers
排除标准
- •Known allergy/hypersensitivity to the dressing
- •Pregnant women
- •Underlying or diagnosed with serious diseases or deemed unsuitable for this clinical study by the study's clinician
- •Dry wounds
- •Being treated with a high dose of steroids or immunosuppressant therapy or systemic antibiotics
- •Presenting a progressive neoplastic lesion treated with radiotherapy or chemotherapy
- •Patients who had Deep Vein Thrombosis in the previous 3 months
- •Ulcers with clinical signs of infection or erysipelas of the lower limb or biofilm
- •Subjects included in clinical study at present or during the past 30 days
- •Clinical suspicion of osteomyelitis
结局指标
主要结局
Wound Area Measurement
时间窗: Week 1, Week 2, Week 3, Week 4
Wound area (cm2) to be recorded at baseline and weekly visits to assess % change in wound area.
次要结局
- Changes in Epithilizing / Granulating Tissues(Week 1, Week 2, Week 3, Week 4)
- Scar Management(Week 4)
- Pain Management(Week 1, Week 2, Week 3, Week 4)
- Clinician opinion related to dressing(Week 4)
- Exudate Management(Week 1, Week 2, Week 3, Week 4)
- Bates Janesen Wound Assessment Score(Week 1, Week 2, Week 3, Week 4)
- Patient opinion related to dressing(Week 4)
研究者
研究点 (7)
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