NCT02732886已完成不适用
A Pilot Study to Compare Efficacy of Medifoam® and Betafoam® as a New Dressing Including Povidone-iodine, in Patients With Diabetes Foot Ulcer
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
- 71
- 试验地点
- 1
- 主要终点
- Proportion of subjects with a target ulcer which achieves complete wound closure in 8 weeks
研究概览
简要总结
This study is to compare the efficacy and safety of Medifoam® and Betafoam®, which is a new dressing that contains povidone-iodine, in patients with diabetes foot ulcer. 70 patients (35 each arm) are targeted to be enrolled in this study. Treatment follow periods are 8weeks.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult of age ≥19 years at the time of informed consent
- •Foot ulcers related to diabetes mellitus:
- •Type I or II diabetes mellitus with HbA1c <10%, or serum creatinine ≤ 200 μmol/l
- •Wagner grade I-II (Partial- or full- thickness and not involving bone, tendon, or capsule (probing to tendon or capsule)
- •Post -debridement ulcer bed size ≥ 1*1cm2
- •No clinical signs of infection & necrosis
- •Site at anywhere below ankle
- •No vascular abnormalities of the foot by palpation (i.e. the dorsalis pedis should be examined by the physician and characterized as present or absent)
排除标准
- •Pregnant & lactating females
- •Known allergy to the dressing product including povidone iodine
- •Known hyperthyroidism or other acute thyroid diseases
- •Subject with clinical infection who should be administered antibiotics continuously after enrolment
- •Subject has any condition(s) that seriously compromises the patient's ability to complete this study.
- •Subject has participated in interventional study utilizing an investigational drug within the previous 30 days
- •Subjects with known immune-suppressed state; who undergo chemotherapy or with end-stage renal disease requiring haemodialysis or had kidney transplant surgery previously and with immunosuppressant specifically
- •Subjects requiring skin grafting per physician's discretion
- •Vulnerable subjects as defined by Good Clinical Practice guidelines.
研究组 & 干预措施
Betafoam®
Experimental
Brand name: Betafoam® Generic term: Wound dressing with 3% povidone iodine
干预措施: Betafoam® (Device)
Medifoam®
Active Comparator
Brand name: Medifoam® Generic term: Wound dressing
干预措施: Medifoam® (Device)
结局指标
主要结局
Proportion of subjects with a target ulcer which achieves complete wound closure in 8 weeks
时间窗: 8 weeks
Skin re-epithelialization without drainage or dressing requirements
次要结局
- Proportion of subjects with a target ulcer which achieves complete wound closure in 4 weeks(4 weeks)
- Wound infection rate until completion of skin re-epithelialization(8 weeks)
- Number of days till completion of wound healing from baseline(8 weeks)
- Safety as determined through collection of adverse events(8 weeks)
- Patient's level of satisfaction with treatment measured weekly using numeric rating scale (NRS)(8 weeks)
- Total number of the dressing change and mean number of dressing change per day compared to wound healing period(8 weeks)
- Change amount and change rate of the target ulcer size after using the investigational device(8 weeks)
研究者
研究点 (1)
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