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临床试验/CTRI/2023/04/051654
CTRI/2023/04/051654已完成不适用

A single blind randomized controlled clinical study comparing the efficacy of platelet-rich plasma (PRP) and silver ion dressing on venous ulcer healing

Institute of medical sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年4月25日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
comparing effect of topical platelet rich plasma and silver ion on venous ulcer healing

研究概览

简要总结

Venous ulcer is a common public health problem. Venous leg ulcer healing process is complex as it affects both macro and micro vasculature. Autologous platelet rich plasma being a rich source of growth factors, may be effective. It is safe, easy to prepare and cost effective. On the other hand the microbicidal action of silver ions has also been tried for ulcer healing. In our study patients with venous leg ulcer will be treated by topical application of PRP and silver ion dressing and the rate of ulcer healing compared over a duration of 6 weeks. Quality of life assessment will also be done by the use of Aberdeen varicose vein questionnaire.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Venous leg ulcer with ABPI more than 0.8 with normal platelet count.
  • VLU grading 0-5A & 6A ( according to modified TIME-H score).

排除标准

  • Modified TIME-H score [5B & 6B-8 (healing unlikely)
  • VLU area > 100sq cm
  • Immune-compromised
  • Coagulation disorders.

结局指标

主要结局

comparing effect of topical platelet rich plasma and silver ion on venous ulcer healing

时间窗: 6 weeks

次要结局

  • Improvement in pain score(6 weeks)

研究者

发起方
Institute of medical sciences
申办方类型
Government medical college

研究点 (1)

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