CTRI/2009/091/000250未知4 期
A randomised controlled clinical trial to investigate the role of autologous bone marrow derived cells in the healing of chronic wounds
Christian Medical College, Vellore, Tamil Nadu, India1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 待定
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of wound healing as defined by a decrease in wound size over time
研究概览
简要总结
This study is a randomized, single blinded, placebo controlled parallel group trial assessing whether local application of autologous bone marrow derived cells to chronic wounds will augment their healing. The primary outcome is rate of wound healing as measured by decrease in wound size over 3 months. The secondary outcome is standardization of the technique of local application of autologous bone marrow derived cells to chronic wounds.
研究设计
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
入选标准
- •Male or female patients with chronic wounds that had not healed for 3 months or more.
- •Wounds where primary closure could not be achieved.
- •Wounds which were unsuitable for skin grafting.
排除标准
- •Wounds with active infection defined as copious pus discharge from the wound.
- •Wounds where distal pulses were not palpable Wounds more than 15 cm in any one dimension.
- •Patients with Hansen?s disease.
- •Patients who were pregnant.
- •Patients who were on chemotherapy.
- •Patients who were diagnosed with hematological disease.
结局指标
主要结局
Rate of wound healing as defined by a decrease in wound size over time
时间窗: Follow up every 2 weeks for 3 months
次要结局
- Standardization of technique of local application of bone marrow cells to chronic wounds(Follow up every 2 weeks for 3 months)
研究者
研究点 (1)
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