NCT00330265Unknown2 期
A Prospective, Randomized, Controlled, Unmasked, Multiple Treatment, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of an Interactive Wound Dressing Containing Cultured Keratinocytes Versus Conventional Wound Therapy for the Treatment of Diabetic Foot Ulcers
KeraCure42 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 300
- 试验地点
- 42
- 主要终点
- Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment
研究概览
简要总结
The objective of this study is to determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus.
This is a prospective, randomized, multi-center, unmasked, controlled study. All patients will receive care for the diabetic foot ulcer during the study.
Participation in the study is for 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Participants included in the study must:
- •Have Type 1 or Type 2 diabetes mellitus
- •Have a diabetic foot ulcer on the bottom of the foot or heal which has been present for three (3) weeks but less than two (2) years and is sufficient size to qualify for the study
- •Be able to visit the study doctor regularly for 24 weeks
排除标准
- •Participants may not be included if:
- •The diabetic foot ulcer is infected
- •They have poor circulation in their study foot
- •Cannot or will not wear a special boot to take pressure off the study ulcer
- •They have certain other diseases or laboratory values which are not within a specified range
结局指标
主要结局
Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (42)
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