跳至主要内容
临床试验/NCT01408277
NCT01408277已完成4 期

A Comparison of Collagenase Santyl® Ointment Used Adjunctively to Sharp Surgical Debridement and Sharp Surgical Debridement in the Care of Diabetic Foot Wounds

Healthpoint14 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
Healthpoint
入组人数
55
试验地点
14
主要终点
Mean Percent Change in Wound Area

研究概览

简要总结

Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the subjects will continue into the follow-up phase for an additional 6 weeks. Study doctors will look at the wound in the office each week (up to 12 weeks) to see if the wound is healing. Depending on a number of factors at each office visit, the study doctors may also use a procedure called sharp debridement to remove dead skin from the wound.

This study will test the hypothesis that daily treatment of diabetic foot wounds with Santyl will result in more rapid healing, healthier wounds, and fewer required sharp debridements over the study period than for diabetic foot wounds treated in other ways.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Mean Percent Change in Wound Area

时间窗: 6 and 12 weeks

Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.

次要结局

未报告次要终点

研究者

发起方
Healthpoint
申办方类型
Industry
责任方
Sponsor

研究点 (14)

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