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临床试验/NCT05777213
NCT05777213已完成1 期

Effectiveness of Giving Injection of Human Umbilical Cord Secretome in the Case of Trophic Ulcers (Pre-post Intervention)

Yohanes Firmansyah, dr, MH, MM4 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
27
试验地点
4
主要终点
Changes in Wound Size - Area

研究概览

简要总结

Background: Trophic ulcer is one of the complications that arise due to leprosy infection of the skin and includes diseases that trigger permanent disability and reduce the quality of life of the person. The facts in the field that more than 50% of chronic ulcers, especially trophic ulcers due to leprosy fail to heal with usual treatment. Therefore it is important to do a new method in healing trophic ulcers. Stem cell therapy or one of them is conditioned medium mesenchymal stem cell is a promising therapy because of its biological and physiological processes resembling the mechanism of wound healing Method: This research is a clinical trial research "Open Trial". Phase 1 to see the side effects caused by the intervention. Minimum sample size of 20 respondents with trophic ulcers due to leprosy that is difficult to resolve with usual treatment. The main outcome is wound healing in terms of the length and extent of the wound. The secondary outcome is treatment toxicity 4 weeks after administration. Follow-up visits will be scheduled at 2, 4, and 12 weeks post-treatment. If the results confirm safety, feasibility and potential efficacy, large multicenter randomized controlled trials with longer follow-up will begin with a focus on the effectiveness of therapy

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic ulcers in Morbus Hansen's patients aged 18-80 years
  • Not recovering with routine therapy for at least 1 months
  • Trophic ulcers degrees 2 and 3
  • Willing to take part in the study
  • As well as with the respondent's good health to follow this study.

排除标准

  • Patients who took anticoagulants,
  • Patients had hypertension
  • Patients had any staging kidney failure
  • Patients had a history of blood disorders and pregnancy.

结局指标

主要结局

Changes in Wound Size - Area

时间窗: 4 weeks

Digital measurements carried out by multiplying the length and width of the wound over time (1 time per week for 4 weeks) in units of cm squares

Changes in Wound Size - Length

时间窗: 4 weeks

Digital measurements of Length carried out using a rule from time to time (1 time per week for 4 weeks) with units in cm

Changes in Wound Size - Width

时间窗: 4 weeks

Digital measurements of Width carried out using a rule from time to time (1 time per week for 4 weeks) with units in cm

次要结局

未报告次要终点

研究者

发起方
Yohanes Firmansyah, dr, MH, MM
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yohanes Firmansyah, dr, MH, MM

Researcher

Tarumanagara University

研究点 (4)

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