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临床试验/IRCT20200220046560N1
IRCT20200220046560N1已完成2 期

Evaluation of The efficacy of topical Melatonin on healing of diabetic foot ulcers in a double blind placebo-controlled clinical trial

Oroumia University of Medical Sciences0 个研究点目标入组 36 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
36

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 no limit(—)
性别
All

入选标准

  • Patients equal and more18 years old
  • Grade 1 or 2 diabetic foot ulcers based on wagner
  • Patients with HgbA1c<=10%
  • Obtain informed consent
  • The size of the wound is more than one cm2
  • Index affected by ankle> 0.4 or Color Doppler Ultrasound with no result of severe vascular involvement

排除标准

  • Need to have injectable antibiotics
  • Allergy to topical melatonin product
  • Patients with uncontrolled epilepsy
  • Pregnancy and lactation
  • Any skin disorder leads to ulcer
  • Causes of wounds other than diabetes such as trauma
  • Wounds happened in less than 2 weeks
  • Patients treated with chemotherapy or radiotherapy
  • Use of drugs that interfere with wound healing, such as: corticosteroids at least the equivalent dose of 40 mg of prednisolone, mycophenolate, cyclosporine, tacrolimus, rituximab
  • Patients with renal disease at stage 5(GFR<15 ml/min) or on dialysis

研究者

发起方
Oroumia University of Medical Sciences

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