Effectiveness of Giving Injection of Human Umbilical Cord Secretome in the Case of Trophic Ulcers (Pre-post Intervention)
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
- 否
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
Yohanes Firmansyah, dr, MH, MM
Researcher
Tarumanagara University
